MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM; PIN, FIXATION, THREADED

Catalog Number	50382110S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "during a precision navigation tka case.The apex pin snapped inside the patients tibia during insertion at the start of the case.The broken end could not be retrieved and a new pin was opened and used.Surgical delay while trying to retrieve the broken end.".
Event or Problem Description
As reported: "during a precision navigation tka case.The apex pin snapped inside the patients tibia during insertion at the start of the case.The broken end could not be retrieved and a new pin was opened and used.Surgical delay while trying to retrieve the broken end.".
Additional Manufacturer Narrative
The complaint could be confirmed, since the information for evaluation matches the alleged failure.The investigation revealed the following: inspection of the image indicates that the tip of the pin appears to be broken off.Additionally, there are visible scratches on both the shank and the recess area.For further evaluation, it is necessary to receive the part back for physical inspection.Further investigation of the manufacturing documents of the pin has shown, that this item is made out of implant steel.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23144772
• Report Number: 0008031020-2025-01638
• Device Sequence Number: 8888963
• Product Code: JDW
• UDI-Device Identifier: 04546540435408
• UDI-Public: (01)04546540435408(11)240907(17)290831(10)AK1546
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K001886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 50382110S
• Device Lot Number: AK1546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2024
• 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: 49 YR
• Patient Sex: Unknown
• Patient Weight: 109 KG