MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL RETROGRADE T2 ALPHA FEMUR RETROGRADE Ø11X360MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23391136S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
It was reported: "an alpha retrograde nail broke through the middle of the most distal static option hole (above the oblong dynamic hole).Approximately 2 months after implantation.Patient was weight bearing and walking; did not experience a fall".
Event or Problem Description
It was reported: "an alpha retrograde nail broke through the middle of the most distal static option hole (above the oblong dynamic hole).Approximately 2 months after implantation.Patient was weight bearing and walking; did not experience a fall".
Additional Manufacturer Narrative
Correction - please refer to d1 product long description.The reported event could be confirmed since the device was not returned for evaluation but with an available radiograph event could be confirmed.With the available radiograph formal medical opinion was sought: with the provided limited information the only thing that can be noticed is the limited amount of bone healing that occurred from implantation to explantation in approximately 12 weeks.But further could not be identified by with limited provided details.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.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 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: FEMORAL NAIL RETROGRADE T2 ALPHA FEMUR RETROGRADE Ø11X360MM
• 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: 19420718
• Report Number: 0009610622-2024-00254
• Device Sequence Number: 15488716
• Product Code: HSB
• UDI-Device Identifier: 07613327293593
• UDI-Public: 07613327293593
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• 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): 07/24/2024

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 Catalogue Number: 23391136S
• Device Lot Number: K15A8CD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2023
• 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: Unknown