NA 7210573Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010511232), received between Apr 19, 2019 and Nov 26, 2024 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE STABILIZATION SHOULDER KIT ARRIVED DAMAGED FROM MOISTURE LEAK THROUGH THE PACKAGE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787894 ↗
• MalfunctionSep 10, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING SET UP, AFTER THE USER OPENED THE SHOULDER STABILIZATION KIT, IT WAS FOUND THAT IT WAS DIRTY, IT HAD FINGER MARKS (SIMILAR TO FINGERPRINTS). THE FINGER PRINTS WERE FOUND IN THE INTERNAL PACKAGE. THE MATERIAL WAS NOT USED IN THE SURGERY. THERE WAS A SMITH AND NEPHEW BACK-UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181887 ↗
• MalfunctionMay 29, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP FOR AN ARTHROSCOPY, THE STERILE PACKAGE OF THE STABILIZATION SHOULDER KIT WAS ALREADY OPENED BEFORE USED. THERE WAS A S+N BACK UP DEVICE AVAILABLE. THERE WAS NO DELAY REPORTED AND THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19417885 ↗
• MalfunctionMay 31, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING PROCEDURE, OUTSIDE THE PATIENT, THE KIT STABILIZATION SHOULDER (12) WAS MIXED WITH A HAIR WHEN THE PACKAGE WAS OPENED. UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11910730 ↗
• MalfunctionMar 8, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAFF FOUND THAT THE CUFF WAS MIXED WITH A HAIR WHEN THE PACKAGE WAS OPENED. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440189 ↗
• InjuryDec 2, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT, DURING THE PROCEDURE, WHEN THE PACKAGE WAS OPENED THE SHOULDER STABILIZATION KIT'S BANDAGE WAS FOUND TO BE DAMAGED AND BROKEN WHEN IT WAS STRETCHED. A COMPETITOR DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10934613 ↗
• InjuryOct 26, 2020Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE PACKAGE WAS OPENED, THE BANDAGE WAS DAMAGED AND BROKEN WHEN IT WAS STRETCHED. NO DELAY AND A COMPETITOR DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10733935 ↗
• InjuryOct 6, 2020Break; Break

  IT WAS REPORTED THAT DURING THE ARCR PROCEDURE, THE BANDAGE COULD NOT BE PEELED OFF FIRMLY AND WAS BROKEN WHEN IT WAS STRETCHED. NO DELAY AND A BACK UP FROM A COMPETITOR WAS USED TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10639103 ↗
• MalfunctionSep 15, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, THE COBAN THAT HOLDS THE PATIENT'S ARM TEARS DURING USE. IT DID NOT HOLD THE ARM WELL AND IT IS AT RISK OF FALLING FROM THE HANDLE OF THE SPIDER DEVICE. NO SIGNIFICANT DELAY AND IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10534968 ↗
• InjuryJul 24, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ELASTIC BAND OF THE SHOULDER STABILIZATION INCLUDED WITHIN THE KIT WAS WEARING AND TEARING EASILY; IT DID NOT ALLOW TO ADJUST IT IN THE PATIENT'S EXTREMITY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A COMPETITOR BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10321474 ↗
• InjuryJul 22, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, WHEN THE PACKAGE WAS OPENED, THE BANDAGE COULD NOT BE PEELED OFF FIRMLY AND BROKE WHEN IT WAS STRETCHED. THERE WAS NO DELAY IN THE CASE. THE PROCEDURE WAS FINISHED WITH A COMPETITOR'S DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10311984 ↗
• MalfunctionMar 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE PACKAGE WAS OPENED THE BANDAGE WAS FOUND DAMAGED AND BROKEN WHEN IT WAS STRETCHED. NO PATIENT INJURIES OR DELAY REPORTED. AS THE INFORMATION RECEIVED THE PROCEDURE WAS COMPLETED USING A HOSPITAL BANDAGE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9892174 ↗
• MalfunctionMar 24, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE SURGEON USED THE SHOULDER STABILIZATION KIT BUT THE BANDAGE WAS DAMAGED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH A DEVICE FROM A COMPETITOR BRAND. NO DELAY OR PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9873296 ↗
• MalfunctionNov 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY, WHEN UNPACKING, THE FOAM PIECE OF THE STABILIZATION SHOULDER WAS TOO SHORT. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES BY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9367108 ↗
• MalfunctionApr 19, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, WHEN THE STAFF APPLIED THE BLUE FOAM PAD TO THE PATIENT, IT BROKE OFF. AS THERE WAS NOT ANY BACK-UP DEVICE AVAILABLE, IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE SURGERY WAS DELAYED ONLY 5 MIN. THE PATIENT DID NOT SUFFER ANY ADVERSE EVENT OR INJURY AS CONSEQUENCE OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532163 ↗