MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE Ø9X380MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2331-0938S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
"patient reported she was walking when she felt a snap in her leg.She reported she felt pain in her leg for a week before the event.After further follow evaluation, results showed the proximal end of the antegrade femoral nail had broken near the level of the lag screws.Revision surgery performed.Replacement device used: gamma long nail with rc lag screw.".
Additional Manufacturer Narrative
The reported event was confirmed on provided x-ray.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The labelling clearly points out potential causes leading to implant breakage.The item in question had allegedly broken after an implantation period of approx.2,5 months.Since no item was available the kind of breakage could not e determined.Further medical documents were not provided.Thus, a medical review was not possible.The surgeon's instructions regarding post operative load bearing and the patient¿s actual behavior remained unknown - thus, it could not be determined if the patient had been compliant.With available information a product deficiency was not verified.Due to missing item a root cause could not be determined.In case further essential information becomes available we reserve the right to re-open the investigation and to re-assess the root cause.
Event or Problem Description
"patient reported she was walking when she felt a snap in her leg.She reported she felt pain in her leg for a week before the event.After further follow evaluation, results showed the proximal end of the antegrade femoral nail had broken near the level of the lag screws.Revision surgery performed.Replacement device used: gamma long nail with rc lag screw".

• Brand Name: FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE Ø9X380MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 13552894
• Report Number: 0009610622-2022-00061
• Device Sequence Number: 17133954
• Product Code: HSB
• UDI-Device Identifier: 07613327284713
• UDI-Public: 07613327284713
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: 09/30/2023
• Device Model Number: 2331-0938S
• Device Catalogue Number: 23310938S
• Device Lot Number: K0EE7D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2018
• 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: 58 YR
• Patient Sex: Female