MULTIFIX OM-2300Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00817470000580), received between Dec 5, 2017 and Sep 3, 2019 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING SURGERY WHEN IMPLANTING LATERAL ROW ANCHOR, DOCTOR USED THE AWL DILATOR AND WAS PLACING THE 5.5 MULTIFIX IN THE HOLE WHEN THEY NOTICED A CRACK IN THE TIP OF THE ANCHOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8958040 ↗
• MalfunctionSep 3, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, WHEN THE DEVICE WAS INSERTED, THE TIP CRACKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY CAUSED BY THE CONDITION REPORTED. PATIENT INJURIES WERE NOT 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 8957990 ↗
• InjuryAug 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A LEFT SHOULDER SCOPE, REVISION SAD AND RCR ON (B)(6)2016 DUE TO A RECURRENT NEAR FULL THICKNESS SUPRASPINATUS TEAR CONFIRMED ON MR-ARTHROGRAM ON (B)(6) 2016. PATIENT WAS ALSO TREATED WITH PHYSICAL THERAPY. THE OUTCOME OF THE PATIENT IS RECOVERED WITH SEQUELAE.

  Patient problems: Injury

  MAUDE report 8873520 ↗
• InjuryJul 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY, THE PATIENT HAD A RIGHT SHOULDER ADHESIVE CAPSULITIS ON (B)(6) 2016. THE EVENT WAS TREATED WITH PHYSICAL THERAPY AND PATIENT HAD A S/P R SHOULDER SCOPE, SAD, LYSIS OF ADHESIONS, CAPSULAR RELEASE AND MUGA ON (B)(6) 2016. THE OUTCOME OF THE PATIENT IS RECOVERED.

  Patient problems: Injury

  MAUDE report 8814676 ↗
• InjuryJul 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY, THE PATIENT HAD A RIGHT SHOULDER ADHESIVE CAPSULITIS ON (B)(6) 2016. THE EVENT WAS TREATED WITH PHYSICAL THERAPY AND PATIENT HAD A S/P R SHOULDER SCOPE, SAD, LYSIS OF ADHESIONS, CAPSULAR RELEASE AND MUGA ON (B)(6) 2016. THE OUTCOME OF THE PATIENT IS RECOVERED.

  Patient problems: Injury

  MAUDE report 8814671 ↗
• MalfunctionJun 5, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT HAD REVISION SURGERY FOR LOOSE ANCHOR IN THE SUB ACROMIAL SPACE. ONLY THE SCREW PART OF THE ANCHOR WAS LOOSE, THE TIP WAS STILL IN PLACE AND COULD NOT BE RETRIEVED. THE SCREW WAS RETRIEVED AND DISCARDED. A REVISION RCR WAS PERFORMED ON THE ANTERIOR PORTION OF THE SUPRA SPINATUS USING A 6.5MM MULTIFIX-S ULTRA.

  Patient problems: No Information

  MAUDE report 7571504 ↗
• MalfunctionMar 1, 2018Break

  IT WAS REPORTED THAT THE MULTIFIX S BROKE. THE PATIENT HAD NORMAL TO POOR BONE QUALITY. EVERYTHING WAS REMOVED.

  Patient problems: No Code Available

  MAUDE report 7306353 ↗
• MalfunctionJan 5, 2018Break

  IT WAS REPORTED THAT THE DEVICE BROKE WHEN THE THREADS WERE GOING THROUGH DURING SURGERY. THE SURGEON CHANGED THE DEVICE TO A REF (B)(4) TO END THE SURGERY. THE PIECE REMAIN SECURED INSIDE THE PATIENT. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7167255 ↗
• MalfunctionDec 5, 2017Break

  IT WAS REPORTED THAT THE ITEM BROKE DUE TO HARD BONE, IT BROKE BY THE BICIPITAL GROOVE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7085203 ↗