MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-1380S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a broken gamma nail 6 months after implantation.The patient was revised to a recon nail.
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 in a supplemental report.
Event or Problem Description
It was reported that there was a broken gamma nail 6 months after implantation.The patient was revised to a recon nail.
Additional Manufacturer Narrative
Please note the correction to h6 method code.The reported event could be confirmed based on the x-ray received.A device inspection was not possible since the affected device was not returned.A post-operative x-ray was received, confirming a trochanteric femoral fracture and the breakage of the nail in two parts at the level of the proximal hole 6 months after implantation.However, it was not possible to make any statement on the root cause of the fracture.The x-ray did not give any indication of poor bone quality or of medical error.Based on investigation, the root cause of the breakage could not be identified.More information of the patient and of the events leading to the fracture as well as the device are needed in order to be able to make precise statements on the causes of the breakage.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X380MM X 125°
• 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: 16086446
• Report Number: 0009610622-2023-00001
• Device Sequence Number: 20509483
• Product Code: HSB
• UDI-Device Identifier: 07613252273844
• UDI-Public: 07613252273844
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200869
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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: 3425-1380S
• Device Catalogue Number: 34251380S
• Device Lot Number: K01A62C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2022
• 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: 66 YR
• Patient Sex: Female