MAUDE Adverse Event Report: Stryker GmbH GAMMA3 - TARGET DEVICE; 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	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
While drilling for the distal locking screws, the drill bit went off course due to the gamma3 guide.According to the customer, the correct guide sleeve for the selected implant was used.Replacement was available.Additional information: it was not the distal locking screw that was the problem.The problem was the lag screw step drill.The lag screw reamer didn¿t hit the hole in the nail.The customer used the correct g3 targeting sleeve for the nail.The setup was checked twice.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
While drilling for the distal locking screws, the drill bit went off course due to the gamma3 guide.According to the customer, the correct guide sleeve for the selected implant was used.Replacement was available.Additional information: it was not the distal locking screw that was the problem.The problem was the lag screw step drill.The lag screw reamer didn¿t hit the hole in the nail.The customer used the correct g3 targeting sleeve for the nail.The setup was checked twice.
Additional Manufacturer Narrative
Please note the correction to d4 lot#.The reported event could not be confirmed since the returned device was found to be functional & conforming to specifications.The received target device showed significant signs of usage evident by presence of scratches over the body and worn off surface, with the white print turning to fawn from white.No major damage evident except for worn off edges in one of the slots.A pre-surgical functional test was conducted on the returned target device with a sample nail, speedlock sleeve, tissue protection sleeve and drills.The nail could be assembled and targeting of all the possible locking options could be done without any interference.Thus the alleged issue could not be reproduced, hence could not be confirmed.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 on the above investigation, the root cause of the issue is deemed to be user related.The exact reason as to why there were issues with the assembly but most likely it is due to application error.If any additional information is provided, the investigation will be reassessed.

• Brand Name: GAMMA3 - TARGET DEVICE
• 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 GmbH; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25217662
• Report Number: 0008031020-2026-00674
• Device Sequence Number: 18594510
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/16/2026

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: KME919481
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2023
• 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