MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 120°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3120-1200S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports that a gamma nail broke during surgery.
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction: please refer to g1 reporting contact, h6 health impact code.The reported event could be confirmed, since the device was returned and shows a breakage at the level of the lag screw hole.Traces of miss-drilling can be seen on the inside surface of the screw hole (shiny surface all through the length of the hole progressing through the bore towards medial).The drill marks were generated by a deviated lag screw step drill which most likely had created the starting point of the fracture (notching effect) somewhere at the lateral edge.Multiple scratches can also be noticed going in several directions in the inner surface of the lag screw hole.These last marks can be attributed to the attempts of the hcp to remove the nail from the patient's body, and not in relation of the nail breaking.An analysis of the surface breakage of the bridges shows shiny surfaces, which are a clear indicator of fatigue fractures.Indeed, the nail most probably broke at the level of one of the bridges first, resulting in the two parts of the nail (proximal and distal) rubbing against each other, and creating the shiny surface that can be seen in the picture.Due to heavy marks, the true origin point of the fracture could not be traced.Based on the mentioned facts above, it can be stated that the nail was at least partially broken before the extraction surgery, due to fatigue.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 more information is provided, the case will be reassessed.
Event or Problem Description
The customer reports that a gamma nail broke during surgery.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 120°
• 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: 12755710
• Report Number: 0009610622-2021-00773
• Device Sequence Number: 17225034
• Product Code: HSB
• UDI-Device Identifier: 04546540375032
• UDI-Public: 04546540375032
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 3120-1200S
• Device Catalogue Number: 31201200S
• Device Lot Number: K0BE199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 11/06/2021
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2015
• 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
• Patient Sex: Unknown