MAUDE Adverse Event Report: STRYKER GMBH ANKLE ARTHRODESIS NAIL, LEFT T2 ANKLE Ø12X300MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18181230S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Removal of a broken t2 ankle nail.It was detected by x-ray before the operation, the nail was implanted 1-2 years earlier at a different location.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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 or manufacturing related problems were found during the investigation.More detailed information about the complaint event as well as the affected device 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.
Event or Problem Description
Removal of a broken t2 ankle nail.It was detected by x-ray before the operation; the nail was implanted 1-2 years earlier at a different location.
Additional Manufacturer Narrative
Correction - please refer to d9, the product was returned, h6 (device, method & results) codes.The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the ankle nail was received and found broken from the oblong hole.Both the distal and proximal fragments show lines of rest which indicate that the nail has broken in fatigue manner.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 or manufacturing related problems were found during the investigation.No product related issue could be detected during the performed investigation of the returned device.The implant ultimately failed to withstand the applied force, resulting in material overload and fatigue failure.Based on the limited information available, the root cause of the reported event cannot be defined as this is often muti-factorial: the location of the fracture and the technical aspects of the surgical procedure could have contributed to the event.Furthermore, patient condition and activity levels post-op may also have contributed to an inadequate load distribution, and therefore the breakage of the implant.If more information is provided, the case will be reassessed.
Event or Problem Description
Removal of a broken t2 ankle nail.It was detected by x-ray before the operation, the nail was implanted 1-2 years earlier at a different location.

• Brand Name: ANKLE ARTHRODESIS NAIL, LEFT T2 ANKLE Ø12X300MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21401259
• Report Number: 0008031020-2025-00306
• Device Sequence Number: 9382412
• Product Code: HSB
• UDI-Device Identifier: 04546540673367
• UDI-Public: (01)04546540673367(11)210715(17)260630(10)K042F03
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2026

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: Lay User/Patient
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: 18181230S
• Device Lot Number: K042F03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 05/02/2025; 01/12/2026
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/29/2025; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• 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: Required Intervention
• Patient Sex: Male