MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - INTERMEDIATE TARGETING SLEEVE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14202100
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "distal drill interfered with the nail and could not drill into the nail easily.The physician could drill with difficulty while having the sleeve controlled by fingers.".
Event or Problem Description
As reported: "distal drill interfered with the nail and could not drill into the nail easily.The physician could drill with difficulty while having the sleeve controlled by fingers.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and found to be functional at distribution site.A device inspection was not possible since the affected device was not returned, but functional test was conducted with the alleged device at the distribution site which confirms that the device was functional in nature.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 the above investigation the root cause can be attributed to user related as the device was found to be functional in nature at distribution end.If more information is provided, the case will be reassessed.

• Brand Name: GAMMA4 - INTERMEDIATE TARGETING SLEEVE
• 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: 23574286
• Report Number: 0008031020-2025-02079
• Device Sequence Number: 16020537
• Product Code: HSB
• UDI-Device Identifier: 07613327591477
• UDI-Public: 07613327591477
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 14202100
• Device Lot Number: KP505118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2023
• 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: Female