MAUDE Adverse Event Report: STRYKER GMBH TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31301180S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device discarded by the hospital.
Event or Problem Description
As reported: "a neck of femur fracture was to be treated with a gamma short nail.During the procedure an issue arose inserting the set screw.Details are unclear but difficulty caused them to remove the set screw and open a spare.Case was then completed without further issues that were raised.".
Event or Problem Description
As reported: "a neck of femur fracture was to be treated with a gamma short nail.During the procedure an issue arose inserting the set screw.Details are unclear but difficulty caused them to remove the set screw and open a spare.Case was then completed without further issues that were raised.".
Additional Manufacturer Narrative
The reported event could be confirmed, although the device was not returned but an image was shared by the customer which confirms the alleged issue.The device was not returned for evaluation but an image of it was shared by the customer which shows signs of misalignment evident by deformed and flattened threads.The deformation mark around the tip region where the transition (square to taper) starts also indicates the same, as under proper insertion this area cannot get deformed.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.Based only on the available information and the image, the issue is deemed to be user related.There are signs of misalignment observed in the set screw which most likely led to inadequate insertion of it during the surgery.If any further information is provided, the complaint report will be updated.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 18482768
• Report Number: 0009610622-2024-00021
• Device Sequence Number: 2747251
• Product Code: HSB
• UDI-Device Identifier: 04546540375124
• UDI-Public: 04546540375124
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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 Catalogue Number: 31301180S
• Device Lot Number: K170CBD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• 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