MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X320MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2333-0932S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "(b)(6) 2022 orif with t2alphagt nail was performed.3 months after surgery, the nail was broken.On (b)(6) 2022, the broken nail was removed and the fracture was re-fixed with t2alphagt.The surgeon's opinion was that the initial surgery nail was too thin and short for the patient's bone, which may have led to the implant fracture.".
Additional Manufacturer Narrative
Correction - d4 (lot#).The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received nail was completely broken in the web at the uppermost a/p hole in the distal part of the nail.The fracture appears to have originated from the lateral side in a fatigue manner evident by lines of rest.The other web broke in an instantaneous manner suggestive of continuous loading.The formation of a shiny surface was caused due to gradual rubbing of the separated parts and locking screw before the nail finally broke.The distal segment of the nail also exhibits similar features.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.Based on the above investigation and available information, the root cause of the failure is deemed to be a combination of user and patient-related factors.As per the initial information, the size of the implanted nail was inadequate for the patient.Consequently, the nail broke due to cyclic overloading in a fatigue manner.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "10-may-2022 orif with t2alphagt nail was performed.3 months after surgery, the nail was broken.On (b)(6) 2022, the broken nail was removed and the fracture was re-fixed with t2alphagt.The surgeon's opinion was that the initial surgery nail was too thin and short for the patient's bone, which may have led to the implant fracture.".

• Brand Name: FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X320MM
• 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: 15377749
• Report Number: 0009610622-2022-00424
• Device Sequence Number: 20225611
• Product Code: HSB
• UDI-Device Identifier: 07613327286489
• UDI-Public: 07613327286489
• 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: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

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: 06/30/2024
• Device Model Number: 2333-0932S
• Device Catalogue Number: 23330932S
• Device Lot Number: K07FA95
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2019
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 52 KG