MAUDE Adverse Event Report: STRYKER TRAUMA KIEL T2 FE RETRO NAIL LNG D11XL400; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2339-1140S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The patient felt a "snap" while walking.X-rays showed a broken nail.Revision surgery was used to remove nail, and replaced with a t2 supracondylar nail and a distal lateral femur plate.
Event or Problem Description
The patient felt a "snap" while walking.X-rays showed a broken nail.Revision surgery was used to remove nail, and replaced with a t2 supracondylar nail and a distal lateral femur plate.
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event was confirmed.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 item received had broken in fatigue manner after an implantation period of approx.2 months.The fracture pattern identified high loading.Medical documents were not provided.Thus, a medical review was not possible.The surgeon's instructions regarding post operative load bearing remained unknown - thus, it could not be determined if the patient had been compliant.With available information a product deficiency was not verified.The item broke due to axial overload which was regarded as patient related.In case substantive information becomes available we reserve the right to re-open the complaint and to re-assess the root cause.
Event or Problem Description
The patient felt a "snap" while walking.X-rays showed a broken nail.Revision surgery was used to remove nail, and replaced with a t2 supracondylar nail and a distal lateral femur plate.

• Brand Name: T2 FE RETRO NAIL LNG D11XL400
• 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: 13573133
• Report Number: 0009610622-2022-00063
• Device Sequence Number: 20311516
• Product Code: HSB
• UDI-Device Identifier: 07613327293746
• UDI-Public: 07613327293746
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: 2339-1140S
• Device Catalogue Number: 23391140S
• Device Lot Number: K091BBD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2021
• 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 Age: 67 YR
• Patient Sex: Male