MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X180MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31251180S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
The end user has reported that during the intervention with gamma3 short, the rod got stuck in the aiming device and the doctor could no longer loosen the screw fixing the rod in the aiming system.Having had 2 instrumentations in the hospital to be able to solve the case, he decided to try with the other instrumentation, blocking the rod here too.Also to mention that the doctor has experience with gamma 3.Following this event, he was forced to use another system from another company.Update on (b)(6) 2025: the surgery was prolonged 1 hour because the doctors tried 2 kit instruments.
Event or Problem Description
The end user has reported that during the intervention with gamma3 short, the rod got stuck in the aiming device and the doctor could no longer loosen the screw fixing the rod in the aiming system.Having had 2 instrumentations in the hospital to be able to solve the case, he decided to try with the other instrumentation, blocking the rod here too.Also to mention that the doctor has experience with gamma 3.Following this event, he was forced to use another system from another company.Update on august 1, 2025: the surgery was prolonged 1 hour because the doctors tried 2 kit instruments.
Additional Manufacturer Narrative
The reported event could not be confirmed since the returned device was found to be functional and conforming to specifications.The device inspection revealed the following: the received target device & nail holding screw showed typical signs of usage evident by presence of scratch marks all over, while no major damage could be observed.The returned nail were in good condition without any signs of damage as apparently, they couldn¿t be used in the surgery.A pre-surgical functional test was done by assembling the returned nails with the target device, nail holding screw and a sample speedlock sleeve.Upon assembling, it was observed that all the devices worked alright in all the targeting positions without any issue.Thus, the alleged issue 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 real reason why disassembling was impaired during the surgery could not be determined, however the issue is deemed to be user related.If any additional information is provided, the investigation will be reassessed.

• Brand Name: GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X180MM X 125DEG
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22814907
• Report Number: 0008031020-2025-01376
• Device Sequence Number: 12197086
• Product Code: HSB
• UDI-Device Identifier: 04546540375070
• UDI-Public: 04546540375070
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: 31251180S
• Device Lot Number: K115CA1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2025
• 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