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

Catalog Number	14200112
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The targeting sleeve movement of the gamma 4 was faulty.The targeting sleeve had come loose from the target device during operation due to the metal pin attached to the sleeve coming loose.
Event or Problem Description
The targeting sleeve movement of the gamma 4 was faulty.The targeting sleeve had come loose from the target device during operation due to the metal pin attached to the sleeve coming loose.
Additional Manufacturer Narrative
The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: both the sleeve and the knob were returned.They can be properly assembled without any issue.The returned sleeve and knob were tested with a compatible and fully functional gamma4 targeting arm sample.The returned devices and the sample targeting arm could be assembled together properly, and worked as intended in several positions.Therefore, it was not possible to confirm the event upon the devices inspection.In addition, the reporter did provide a picture of the allegedly defective sleeve, in comparison to a fully functional one.It can be observed the pin is popping out towards the outside of the sleeve, explaining why the pin no longer engaged with the targeting arm.However, there is no evidence of the knob playing a role in the event, as no picture of the knob was provided and as the pin protrusion only involves the targeting sleeve.Therefore, the knob most likely did not contribute to the reported event.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.

• Brand Name: TARGETING SLEEVE KNOB GAMMA4
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21577183
• Report Number: 0008031020-2025-00393
• Device Sequence Number: 15637787
• Product Code: HSB
• UDI-Device Identifier: 07613327554472
• UDI-Public: 07613327554472
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: 14200112
• Device Lot Number: KP498371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2023
• 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 Age: 88 YR
• Patient Sex: Female