MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL RETROGRADE T2 ALPHA FEMUR RETROGRADE Ø12X360MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23391236S
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: primary surgery was performed on (b)(6) 2023.Revision surgery was performed due to non-union on (b)(6) 2024.Due to a lack of confirmation by sales rep, the surgeon, and the distributor, a different instrument and implant were arrived than the one ordered by surgeon.The implant and instrumentation were re-arranged and the surgery was delayed 2 hours.The patient was post induction of anesthesia.This pi is for the revision surgery.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation, and no other evidence was 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, manufacturing or design 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.
Additional Manufacturer Narrative
Based on the available information the device has been discarded; therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: primary surgery was performed on (b)(6) 2023.Revision surgery was performed due to non-union on (b)(6) 2024.Due to a lack of confirmation by sales rep, the surgeon, and the distributor, a different instrument and implant were arrived than the one ordered by surgeon.The implant and instrumentation were re-arranged and the surgery was delayed 2 hours.The patient was post induction of anesthesia.This pi is for the revision surgery.

• Brand Name: FEMORAL NAIL RETROGRADE T2 ALPHA FEMUR RETROGRADE Ø12X360MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21098526
• Report Number: 0008031020-2025-00005
• Device Sequence Number: 8657242
• Product Code: HSB
• UDI-Device Identifier: 07613327292923
• UDI-Public: (01)07613327292923(11)221212(17)321130(10)K0E8069
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: Lay User/Patient
• Device Catalogue Number: 23391236S
• Device Lot Number: K0E8069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2022
• 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 Age: 49 YR
• Patient Sex: Male