MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE 10X440MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2333-1044S
Date of Event	02/25/2021
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
As reported: "t2 alpha gt nail was put in three months ago, (b)(6) 2020.It broke in 3 months.Revision surgery was on (b)(6) 2021".
Event or Problem Description
As reported: "t2 alpha gt nail was put in three months ago, (b)(6) 2020.It broke in 3 months.Revision surgery was on (b)(6) 2021".
Additional Manufacturer Narrative
The reported event was confirmed.The review of manufacturing documents revealed no deviation in the manufacturing process.Required material properties had been confirmed prior to manufacturing.No nc/capa had been filed for the item in question.Potential revision had been considered in the risk management file with appropriate values not having been exceeded by this case.The labelling already informs about that a temporary implant requires sufficient bone consolidation in order to relieve the nail during the implantation period.The labelling points out that product damage must be avoided.No indications of material, manufacturing or design related deficiencies were found during the investigation.In the case presented a femoral nail gt, right t2 alpha femur antegrade had broken in the webs of the distal recon lag screw hole after an implantation period of allegedly 3 months.The breakage pattern confirmed a fatigue fracture.Nail breakage had been caused by material weakening originated by contact with a deflected drill during preparation of the lag screw canal.Axial load application during the time of implantation contributed to the progress of nail breakage.With available information the cause of the event was regarded as user related contributed by typical loading during the implantation period.In case substantive information becomes available we reserve the right to re-open the investigation with root cause assessment.

• Brand Name: FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE 10X440MM
• 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
• MDR Report Key: 11574390
• Report Number: 0009610622-2021-00432
• Device Sequence Number: 19900114
• Product Code: HSB
• UDI-Device Identifier: 07613327285802
• UDI-Public: 07613327285802
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

1 Device 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: 08/30/2023
• Device Model Number: 2333-1044S
• Device Catalogue Number: 23331044S
• Device Lot Number: K0BF757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No