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	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the primary shoulder surgery, when the surgeon drilled his guide pin into the glenoid through the glenoid guide for his reverse total shoulder, the k-wire seemed to get stuck.As the surgeon pulled back on the guide handle, the k-wire broke off.To complete the case, the surgeon used a pin from the general instrument set.There was no delay and the surgery was completed successfully.The broken fragment was retrieved from the patient.
Additional Manufacturer Narrative
On august 04, 2026 we have received a picture that was analysed.The event description has been updated.Analysis performed by r&d manager: based on the available images, it can be stated that the k-wire is broken approximately 20-30 mm from the tip.It is not possible to determine whether any additional damage occurred to the k-wire, because no image of the remaining part is available.The exact root cause of the breakage cannot be conclusively determined.However, it is likely that the breakage resulted from a non-axial load applied during insertion.Material evaluation: the material specification is aisi 316l according to drawing in force at the time of product, which allows for several grades and material conditions, including but not limited to the 316lvm in extra hard condition.The lot involved was produced to the broader 316l grade.

• Brand Name: Shoulder Instruments
• Common Device Name: Shoulder Disposable pin pack
• Manufacturer (Section D): Medacta International SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 50125770
• Report Number: 3005180920-2026-00820
• Device Sequence Number: 21461043
• Product Code: LXH
• UDI-Device Identifier: 07630971259164
• UDI-Public: 07630971259164
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 14,00001
• Device Lot Number: 2609563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2026
• 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 Sex: Female