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

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 10/18/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event 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.".

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 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
• Type of Device: 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
• MDR Text Key: 285819841
• Report Number: 0009610622-2022-00061
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327284713
• UDI-Public: 07613327284713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female