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

Catalog Number	13200111
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "impossible to remove the nail-holder bolt and therefore the nail-holder from the nail.Obliged to remove the nail mounted on the nail holder and repeat the op with another gamma3 ancillary.Change ancillary and implant.".
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "impossible to remove the nail-holder bolt and therefore the nail-holder from the nail.Obliged to remove the nail mounted on the nail holder and repeat the op with another gamma3 ancillary.Change ancillary and implant.".
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was returned and h6 (method, results and conclusion codes).The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned target device could be confirmed based on the catalog # and lot # marked.The target device was returned assembled with the nail.The devices could be disassembled with the instruments required, however, the disassembling was much harder than usual.Thus, the reported event could be confirmed.After disassembling, it could be observed that the cannulation of the distal part of the target device is covered in dry blood.The blood resulting from the nail insertion could be confirmed as the root cause of the reported event, as it made the instruments disassembling much harder.It must be noted that no major damage was observed on the device.Based on the investigation, the root cause was attributed to blood accumulated around the nail holding screw during the surgery.There were no indications of device or of user related issues.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.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "impossible to remove the nail-holder bolt and therefore the nail-holder from the nail.Obliged to remove the nail mounted on the nail holder and repeat the op with another gamma3 ancillary.Change ancillary and implant.".

• 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 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: 21985734
• Report Number: 0008031020-2025-00874
• Device Sequence Number: 8313375
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: (01)04546540716774(11)220117(10)K0A1B2C
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2025

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: 13200111
• Device Lot Number: KME919184
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 10/21/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 07/15/2025; 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• 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