VERSALOK 210800Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886705001163), received between Jul 17, 2018 and May 8, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE VERSALOK THREADER TAB DEVICE, THAT WHEN THE SURGEON TRIED TO IMPLANT THE ANCHOR INTO THE HUMERUS USING A DEPLOYMENT GUN, THE ANCHOR COULD NOT BE IMPLANTED BECAUSE IT DID NOT EXPAND WHEN THE TRIGGER WAS PULLED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126335 ↗
• MalfunctionMar 12, 2026Unintended Movement

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE VERSALOK THREADER TAB *EA ANCHOR CAME LOOSE DURING PLACEMENT. THERE WAS NO SURGICAL DELAY, AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577887 ↗
• MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, THE VERSALOK THREADER TAB DEVICE, WHEN THE ANCHOR IN QUESTION WAS OPENED, THE THREADER TAB HAD ALREADY COME OFF THE INSERTER, MAKING IT UNUSABLE. ANOTHER PRODUCT WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479614 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT WHILE USING THE VERSALOK THREADER TAB DEVICE, A Y-KNOT WAS INSERTED AS THE MEDIAL ANCHOR, AND VERSALOCK DEVICES WERE USED AS THE LATERAL ANCHORS. ACCORDING TO THE REPORTER, THE FIRST VERSALOCK DEVICE WAS USED WITH NO PROBLEM. HOWEVER, WHEN THE SURGEON ATTEMPTED TO PASS THROUGH THE TAPE OF THE Y-KNOT TO THE SECOND VERSALOCK DEVICE, THE THREADING PART OF THE QUICK LOAD TAB SNAPPED. IT WAS REPORTED THAT THE SURGEON TRIED TO REPAIR IT, BUT IT WAS DIFFICULT, SO THE SURGEON USED A NEW DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369336 ↗
• MalfunctionJun 4, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF REPAIR (ARCR) PROCEDURE IT WAS OBSERVED THAT, AFTER INSERTING THE VERSALOK THREADER TAB ANCHOR DEVICE, AND APPLYING TENSION TO THE SUTURE, THE SURGEON ATTEMPTED TO PRESS-FIT THE DEVICE USING THE GUN, BUT IT DID NOT WORK, AND THE ANCHOR CAME OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143580 ↗
• MalfunctionDec 9, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE FOR SHOULDER, IT WAS FOUND THAT THE FIVE (X5) VERSALOK THREADER TAB DEVICES WERE BEING USED WHEN THE SURGEON ATTEMPTED TO DEPLOY THE ANCHOR IN QUESTION WITH A DEPLOYMENT GUN, BUT THE ANCHOR WAS NOT STABLE AND CAME LOOSE AFTER THE FIRE. FOUR ANCHORS WERE THEN USED, BUT A SIMILAR EVENT OCCURRED AND ALL FIVE ANCHORS FAILED TO DEPLOY IN THE BODY AND CAME LOOSE. WITH ANOTHER IMPLANT, THE TEAR WAS SUTURED AND THE SURGERY WAS COMPLETED. THERE WAS 60 MINUTES SURGICAL DELAY AND NO HARM TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20881008 ↗
• MalfunctionDec 9, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE FOR SHOULDER, IT WAS FOUND THAT THE FIVE (X5) VERSALOK THREADER TAB DEVICES WERE BEING USED WHEN THE SURGEON ATTEMPTED TO DEPLOY THE ANCHOR IN QUESTION WITH A DEPLOYMENT GUN, BUT THE ANCHOR WAS NOT STABLE AND CAME LOOSE AFTER THE FIRE. FOUR ANCHORS WERE THEN USED, BUT A SIMILAR EVENT OCCURRED AND ALL FIVE ANCHORS FAILED TO DEPLOY IN THE BODY AND CAME LOOSE. WITH ANOTHER IMPLANT, THE TEAR WAS SUTURED AND THE SURGERY WAS COMPLETED. THERE WAS 60 MINUTES SURGICAL DELAY AND NO HARM TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880876 ↗
• MalfunctionDec 9, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE FOR SHOULDER, IT WAS FOUND THAT THE FIVE (X5) VERSALOK THREADER TAB DEVICES WERE BEING USED WHEN THE SURGEON ATTEMPTED TO DEPLOY THE ANCHOR IN QUESTION WITH A DEPLOYMENT GUN, BUT THE ANCHOR WAS NOT STABLE AND CAME LOOSE AFTER THE FIRE. FOUR ANCHORS WERE THEN USED, BUT A SIMILAR EVENT OCCURRED AND ALL FIVE ANCHORS FAILED TO DEPLOY IN THE BODY AND CAME LOOSE. WITH ANOTHER IMPLANT, THE TEAR WAS SUTURED AND THE SURGERY WAS COMPLETED. THERE WAS 60 MINUTES SURGICAL DELAY AND NO HARM TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880791 ↗
• MalfunctionDec 9, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE FOR SHOULDER, IT WAS FOUND THAT THE FIVE (X5) VERSALOK THREADER TAB DEVICES WERE BEING USED WHEN THE SURGEON ATTEMPTED TO DEPLOY THE ANCHOR IN QUESTION WITH A DEPLOYMENT GUN, BUT THE ANCHOR WAS NOT STABLE AND CAME LOOSE AFTER THE FIRE. FOUR ANCHORS WERE THEN USED, BUT A SIMILAR EVENT OCCURRED AND ALL FIVE ANCHORS FAILED TO DEPLOY IN THE BODY AND CAME LOOSE. WITH ANOTHER IMPLANT, THE TEAR WAS SUTURED AND THE SURGERY WAS COMPLETED. THERE WAS 60 MINUTES SURGICAL DELAY AND NO HARM TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880721 ↗
• MalfunctionDec 9, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE FOR SHOULDER, IT WAS FOUND THAT THE FIVE (X5) VERSALOK THREADER TAB DEVICES WERE BEING USED WHEN THE SURGEON ATTEMPTED TO DEPLOY THE ANCHOR IN QUESTION WITH A DEPLOYMENT GUN, BUT THE ANCHOR WAS NOT STABLE AND CAME LOOSE AFTER THE FIRE. FOUR ANCHORS WERE THEN USED, BUT A SIMILAR EVENT OCCURRED AND ALL FIVE ANCHORS FAILED TO DEPLOY IN THE BODY AND CAME LOOSE. WITH ANOTHER IMPLANT, THE TEAR WAS SUTURED AND THE SURGERY WAS COMPLETED. THERE WAS 60 MINUTES SURGICAL DELAY AND NO HARM TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880718 ↗
• MalfunctionJul 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED FROM JAPAN DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE VERSALOK DEPLOYMENT GUN DEVICE COULD NOT BE LOCKED AND CAME OFF WITHOUT DEPLOYING THE VERSALOK THREADER TAB DEVICE UPON INSERTION INTO THE GREATER TUBEROSITY OF THE HUMERUS. THEREFORE, THE IMPLANT WAS NOT IMPLANTED. IT WAS REPORTED THAT A TOTAL OF FOUR IMPLANTS WERE USED BUT ALL DID NOT DEPLOY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 60 MINUTES DELAY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751203 ↗
• MalfunctionJul 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 5 OF 5 FOR (B)(4). IT WAS REPORTED FROM JAPAN DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE VERSALOK DEPLOYMENT GUN DEVICE COULD NOT BE LOCKED AND CAME OFF WITHOUT DEPLOYING THE VERSALOK THREADER TAB DEVICE UPON INSERTION INTO THE GREATER TUBEROSITY OF THE HUMERUS. THEREFORE, THE IMPLANT WAS NOT IMPLANTED. IT WAS REPORTED THAT A TOTAL OF FOUR IMPLANTS WERE USED BUT ALL DID NOT DEPLOY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 60 MINUTES DELAY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751200 ↗
• MalfunctionJul 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 3 OF 5 FOR (B)(4). IT WAS REPORTED FROM JAPAN DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE VERSALOK DEPLOYMENT GUN DEVICE COULD NOT BE LOCKED AND CAME OFF WITHOUT DEPLOYING THE VERSALOK THREADER TAB DEVICE UPON INSERTION INTO THE GREATER TUBEROSITY OF THE HUMERUS. THEREFORE, THE IMPLANT WAS NOT IMPLANTED. IT WAS REPORTED THAT A TOTAL OF FOUR IMPLANTS WERE USED BUT ALL DID NOT DEPLOY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 60 MINUTES DELAY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751199 ↗
• MalfunctionJul 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED FROM JAPAN DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE VERSALOK DEPLOYMENT GUN DEVICE COULD NOT BE LOCKED AND CAME OFF WITHOUT DEPLOYING THE VERSALOK THREADER TAB DEVICE UPON INSERTION INTO THE GREATER TUBEROSITY OF THE HUMERUS. THEREFORE, THE IMPLANT WAS NOT IMPLANTED. IT WAS REPORTED THAT A TOTAL OF FOUR IMPLANTS WERE USED BUT ALL DID NOT DEPLOY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 60 MINUTES DELAY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751198 ↗
• MalfunctionJul 2, 2024Migration; Migration

  IT WAS REPORTED FROM JAPAN THAT DURING AN OSTEOSYNTHESIS AND ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE FOR GREATER TUBEROSITY FRACTURE, IT WAS DISCOVERED THAT THE BONE QUALITY WAS POOR, AND THE VERSALOK ANCHOR WITH THREADER TAB DEVICE COULD NOT BE PROPERLY FIXED IN ONE LOCATION. HOWEVER, TISSUE FIXATION WAS FIRMLY SECURED WITH SUTURES. THE VERSALOK ANCHOR WAS DEPLOYED IN TWO PLACES, AND THE OTHER ANCHOR WAS FIXED WITHOUT ANY ISSUES. THE SURGERY WAS COMPLETED UNDER THE SURGEON¿S DECISION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A THIRTY-MINUTE DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656087 ↗
• MalfunctionSep 4, 2019Break; Break

  DEVICE REPORT FROM SYNTHES MITEK REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2019. WHEN THE SURGEON WAS THREADING THE SUTURE TO THE ANCHOR (210800), THE WIRE BROKE. THE PROCEDURE WAS COMPLETED LESS THAN A 30-MINUTE DELAY. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8962602 ↗
• InjuryJul 17, 2018Migration; Migration

  THE CUSTOMER REPORTS THAT THE POST SURGERY RADIOGRAPHY OF THE ROTATOR CUFF REPAIR WITH THE DOUBLE ROW TECHNIQUE (UNDER LOCOREGIONAL ANESTHESIA) SHOWED A GRUBBING-UP OF THE ANCHOR WHICH WAS LOCALISED IN THE SUBACROMIAL SPACE. DURING THE SURGERY, THE ANCHOR ON THE LATERAL SIDE WAS IMPACTED AND LOCKED WITH A GUN. THE SURGICAL SUTURE OF THE CUFF WAS REMOVED. A NEW SURGERY OCCURED THE FOLLOWING MORNING UNDER GENERAL ANESTHESIA WITH A SIMPLE ROW TECHNIQUE. ADDITIONAL INFORMATION FROM AFFILIATE: THERE WAS NO DELAY. A REVISION OCCURED THE NEXT DAY (LOCOREGIONAL ANESTHESIA, GENERAL ANESTHESIA) : 30-40 MINUTES, WITHOUT PROBLEM, BUT THE SURGICAL TECHNIQUE WAS CHANGED, NO MODIFICATION OF THE POST-OP INSTRUCTIONS. THE CONSTRAINTS FOR THE PATIENT : FEELING OF FAILURE, A NEW HOSPITALIZATION, A NEW ANESTHESIA SO A HIGH RISK. NO RISK INCREASED.

  Patient problems: Foreign Body In Patient; Tissue Damage

  MAUDE report 7695792 ↗
• MalfunctionJul 17, 2018Separation Problem; Separation Problem

  OUR AFFILIATE REPORTED THE GUN WAS IN THE LOCKED POSITION, HOWEVER, THE SURGEON WAS NOT ABLE TO DEPLOY THE ANCHOR PIN INTO THE SLEEVE BY SQUEEZING THE TRIGGER. HE ALSO TESTED THE GUN AGAIN BY USING ANOTHER ANCHOR WITH THE SAME RESULT. THE SURGEON FINISHED THE PROCEDURE WITH A PUSHLOCK ANCHOR. NO PATIENT HARM REPORTED. ADDIT INFO THE DEVICE IS BEING DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7692946 ↗
• MalfunctionJul 17, 2018Separation Problem; Separation Problem

  OUR AFFILIATE REPORTED THE GUN WAS IN THE LOCKED POSITION, HOWEVER, THE SURGEON WAS NOT ABLE TO DEPLOY THE ANCHOR PIN INTO THE SLEEVE BY SQUEEZING THE TRIGGER. HE ALSO TESTED THE GUN AGAIN BY USING ANOTHER ANCHOR WITH THE SAME RESULT. THE SURGEON FINISHED THE PROCEDURE WITH A PUSHLOCK ANCHOR. NO PATIENT HARM REPORTED. ADDIT INFO THE DEVICE IS BEING DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7692945 ↗