MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3130-1200S
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Excessive force was used for the insertion of the cephalic screw, it was noticeable that it did not slide well inside the nail.It was checked that everything was well connected.Nail and screw was disassembled and reassembled outside, it continued to rub against the cephalic screw when passing inside of the nail.A new nail and screw was used at the end.There was a delay of 1 hour during the procedure.
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device was found to be fully functional and conforming to specifications.The device inspection revealed the following the received device overall appears to be in an alright state.With a closer look at the lag screw hole, heavy stress marks are visible inside the bore which was caused by the use of excessive force during the insertion of the lag screw.Functional test was performed with the reported lag screw and nail, in which no insertion problem was observed, and the lag screw could be locked as required.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.Based on the investigation, the root cause was attributed to a user related issue since the device is found to be fully functional during the inspection.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Excessive force was used for the insertion of the cephalic screw, it was noticeable that it did not slide well inside the nail.It was checked that everything was well connected.Nail and screw was disassembled and reassembled outside, it continued to rub against the cephalic screw when passing inside of the nail.A new nail and screw was used at the end.There was a delay of 1 hour during the procedure.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 130°
• 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: 13619684
• Report Number: 0009610622-2022-00074
• Device Sequence Number: 4673901
• Product Code: HSB
• UDI-Device Identifier: 04546540375131
• UDI-Public: 04546540375131
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 07/31/2026
• Device Model Number: 3130-1200S
• Device Catalogue Number: 31301200S
• Device Lot Number: K05CC52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• 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
• Patient Sex: Unknown