MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE Ø10X360MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2331-1036S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	06/16/2023
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: "nail breakage was observed at the most proximal screw hole of the distal part.The nail will be removed and revision surgery is scheduled on (b)(6) with a retrograde nail." it was additionally reported that the patient experience pain.
Event or Problem Description
As reported: "nail breakage was observed at the most proximal screw hole of the distal part.The nail will be removed and revision surgery is scheduled on (b)(6) with a retrograde nail." it was additionally reported that the patient experience pain.
Additional Manufacturer Narrative
The reported event could be confirmed since the nail was returned in broken manner.The device inspection revealed the following: the nail was completely broken in the thinned webs of the proximal drill hole for the locking screw.The appearance of the breakage surfaces identified the nail had broken in fatigue manner indicated by lines of rest and missing plastic deformation.The incipient crack had started at the smallest cross sections at lateral.The crack had progressed towards medial.In this area the edge was damaged by a mark.Removed material had weakened the material significantly.Hardness test according to rockwell on the returned item and transferring to tensile strength indicated the material being in accordance with the values in the material specification.The data had initially been confirmed by testing the tensile strength prior to manufacturing.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.A review of only a few x-rays by a hcp revealed ¿initial dynamic locking would have been of advantage to contribute to fracture healing¿ based on investigation, the root cause was attributed to a user related issue.With available information a deficiency of the device was not verified.

• Brand Name: FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE Ø10X360MM
• 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: 17334869
• Report Number: 0009610622-2023-00258
• Device Sequence Number: 6477611
• Product Code: HSB
• UDI-Device Identifier: 07613327289367
• UDI-Public: 07613327289367
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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 Model Number: 2331-1036S
• Device Catalogue Number: 23311036S
• Device Lot Number: K04EF5F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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: 19 YR
• Patient Sex: Male
• Patient Weight: 61 KG