MAUDE Adverse Event Report: STRYKER GMBH TARGET DEVICE GAMMA3; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	13200111
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "when using the gamma3 distal aiming device, the distal holes of the nail were missed after correct adjustment of the aiming device.After inspection by the sales rep, it was determined that the g3 targeting device and the distal targeting device could not be adjusted correctly and were probably warped.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "when using the gamma3 distal aiming device, the distal holes of the nail were missed after correct adjustment of the aiming device.After inspection by the sales rep, it was determined that the g3 targeting device and the distal targeting device could not be adjusted correctly and were probably warped.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was found to be fully functional during testing.The device inspection revealed the following: the received devices show normal signs of usage during visual inspection.No abnormalities related to failure observed on the external surface of both the devices.A functional test was done on the returned devices which showed that the device is fully functional i.E.The drill passed both the distal static hole and distal oblong hole without any interference with the nail.However, a slight deviation of the alignment dots for left and right fixation was observed but the slight differences of the dots is considered secondary because they are only intended as orientation how to turn / position the devices.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 investigation, the root cause was attributed to user related issue as the device is found to be fully functional.If more information is provided, the case will be reassessed.

• Brand Name: TARGET DEVICE GAMMA3
• 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: 19595121
• Report Number: 0009610622-2024-00305
• Device Sequence Number: 4160414
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K123401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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: 13200111
• Device Lot Number: KME914868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown