MAUDE Adverse Event Report: STRYKER TRAUMA KIEL T2 FE RETRO NAIL LNG D9XL300; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2339-0930S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2022
Type of Reportable Event	Serious Injury
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 a distal femur fracture treated with a synthes plate became infected.The plate was removed and the doctor waited for the infection to clear.Once it was clear, a 9mm t2 alpha retrograde nail was inserted.The nail failed and another doctor removed the 9mm nail and replaced it with a larger diameter t2 alpha retrograde nail and a distal femur plate.No issues have been reported since.
Additional Manufacturer Narrative
Please note the corrections to b1 and h6 method codes.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.
Event or Problem Description
It was reported that a distal femur fracture treated with a synthes plate became infected.The plate was removed and the doctor waited for the infection to clear.Once it was clear, a 9mm t2 alpha retrograde nail was inserted.The nail failed and another doctor removed the 9mm nail and replaced it with a larger diameter t2 alpha retrograde nail and a distal femur plate.No issues have been reported since.Additional information: the nail failed because there was a lot of hard ware (competitive retrograde nail and competitive distal femur plate) in the patient previously.A larger diameter needed to be used instead of a 9mm nail.

• Brand Name: T2 FE RETRO NAIL LNG D9XL300
• 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: 15571758
• Report Number: 0009610622-2022-00459
• Device Sequence Number: 11468569
• Product Code: HSB
• UDI-Device Identifier: 07613327292374
• UDI-Public: 07613327292374
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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 Model Number: 2339-0930S
• Device Catalogue Number: 23390930S
• Device Lot Number: K094C79
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• 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 Sex: Unknown