MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER INSTRUMENTS; SHOULDER DISPOSABLE PIN PACK

Model Number	14.00001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 19 aug 2025.Lot 2514097: (b)(4) items manufactured and released on 18-jun-2025.No anomalies found related to the problem.To date, no similar events have been reported on the same lot during the period of review.Details of the specific device that broke (the device is part of a set and details of the set has been reported in the form): 64.10.0422 shoulder disposable k-wire - ø2.5 lot.Mat66573 considering the mat66573, 6092 devices were manufactured.This is the firts event reported of this type on this mat.Conclusions: based on the information available, no definitive root cause can be established, while the device history record review does not indicate any potential manufacturing-related issue.Although it cannot be confirmed, the conditions of surgical variation likely resulted in the applied forces exceeding the inherent limitations of the device resistance as constrained by the collective design inputs.
Event or Problem Description
While reaming the glenoid surface, the surgeon changed the angle which put bending forces through the 2.5mm guide pin and it then broke, leaving the tip of the guide pin inside the glenoid.He was unable to remove the broken tip as it was lodged in the bone, and it was left in the patient.

• Brand Name: SHOULDER INSTRUMENTS
• Common Device Name: SHOULDER DISPOSABLE PIN PACK
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 23036831
• Report Number: 3005180920-2025-00845
• Device Sequence Number: 9514873
• Product Code: LXH
• UDI-Device Identifier: 07630971259164
• UDI-Public: 07630971259164
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 14.00001
• Device Lot Number: 2514097
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male