MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ORTHOLOCK EX-PIN 3 X 110; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6007103110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per the user facility, during a navigated total knee replacement (tkr), 2 tips of the ortholock ex-pins broke off during removal.Following a risk assessment, a decision was made by the surgeon to leave the tips in as they were embedded in the patient¿s bones.The procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Update: h3, h6 device evaluation: follow-up report submitted to document the device evaluation.
Event or Problem Description
No new information.

• Brand Name: ORTHOLOCK EX-PIN 3 X 110
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 22349615
• Report Number: 3015967359-2025-01187
• Device Sequence Number: 20962284
• Product Code: HAW
• UDI-Device Identifier: 54546540503225
• UDI-Public: (01)54546540503225
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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
• Device Catalogue Number: 6007103110
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown