Shoulder Instruments 14.00002Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630971259171), received between May 13, 2025 and Sep 9, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692277 ↗
• MalfunctionSep 9, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692275 ↗
• MalfunctionAug 4, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125772 ↗
• MalfunctionAug 4, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125771 ↗
• MalfunctionJun 30, 2026Fracture

  THEK-WIRE D 2.5 X 200 MM BROKE DURING REAMING OF THE CENTRAL GLENOID PEG. IT IS POSSIBLE THAT THE REAMING WAS NOT PROPERLY ALIGNED DURING THE PREPARATION OF THIS PEG. IT WAS NOT POSSIBLE TO RETRIEVE THE BROKEN FRAGMENT OF THE K-WIRE (APPROXIMATELY 2 CM LONG) DESPITE SEVERAL ATTEMPTS. THE SURGEON COMPLETED THE PROCEDURE AND SUCCESSFULLY IMPLANTED THE SHOULDER PROSTHESIS IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25663782 ↗
• MalfunctionJun 30, 2026Fracture

  DURING A SHOULDER SURGERY, A 2.5 MM K-WIRE WAS INSERTED AND SUBSEQUENTLY BECAME BENT. ACCORDING TO THE INFORMATION PROVIDED, THE DEFORMATION WAS NOT RELATED TO THE PSI GUIDES BUT OCCURRED AS A CONSEQUENCE OF RETRACTOR MANIPULATION AFTER K-WIRE PLACEMENT. DURING THE PREPARATION OF THE PEG HOLE USING THE 35 MM PEG REAMER IN COMBINATION WITH THE STOP GUIDE, SIGNIFICANT RESISTANCE WAS ENCOUNTERED. THIS WAS INITIALLY ATTRIBUTED TO THE PATIENT`S DENSE BONE QUALITY, AND DRILLING WAS CONTINUED WITH ADDITIONAL FORCE. UPON REMOVAL OF THE K-WIRE, IT WAS NOTED THAT A FRAGMENT HAD FRACTURED AND REMAINED IN SITU. NO ATTEMPT WAS MADE TO RETRIEVE THE RETAINED FRAGMENT, AS RETRIEVAL WAS CONSIDERED UNFEASIBLE. THE RETAINED FRAGMENT DID NOT INTERFERE WITH THE IMPLANTATION PROCEDURE, AND THE CUSTOM-MADE IMPLANT WAS SUCCESSFULLY IMPLANTED WITHOUT ANY RELATED COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 25663311 ↗
• MalfunctionJun 17, 2026Fracture

  THE K-WIRE D 2.5 X 200MM BROKE AND WAS LEFT INSIDE THE PATIENT AS IT IS STUCK IN THE BONE AND CANNOT BE REMOVED. PATIENT`S BONE QUALITY REPORTED TO BE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25529110 ↗
• MalfunctionJun 17, 2026Fracture

  THE K-WIRE D 2.5 X 200MM BROKE AND WAS LEFT INSIDE THE PATIENT. PATIENT`S BONE QUALITY REPORTED TO BE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528753 ↗
• MalfunctionMar 18, 2026Break

  AFTER DRILLING THE CENTRAL PEG HOLE FOR THE BASEPLATE, THE K-WIRE FRACTURED. THE FRAGMENT BECAME LODGED IN THE PATIENT`S BONE AND COULD NOT BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24625499 ↗
• MalfunctionMar 3, 2026Break

  WHILE DRILLING THE CENTRAL HOLE FOR THE BASEPLATE COMPONENT, THE K-WIRE FRACTURED. THE BROKEN FRAGMENT COULD NOT BE RETRIEVED, AND THE SURGEON DECIDED TO LEAVE THE FRAGMENT IN THE PATIENT. THE SURGERY WAS PROLONGED BY ABOUT 30 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 24494908 ↗
• MalfunctionMay 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE K-WIRE WAS OBSERVED IN THE PATIENT BODY AFTER THE SITE CLOSURE AT POST-OPERATIVE IMAGE. AFTER THE ISSUE WAS DISCOVERED, THE INCISION WAS PROMPTLY REOPENED AND THE K-WIRE WAS REMOVED. THE CAUSE WAS UNKNOWN, BUT IT WAS POSSIBLE THAT IT WAS PUSHED WHEN DRILLING FOR CENTRAL PEG, THE SURGERY WAS COMPLETED SUCCESSFULLY. DELAY TIME 1 HOUR, TOTAL SURGERY TIME 4 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010869 ↗