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

Catalog Number	14200110
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.
Additional Manufacturer Narrative
The reported event could be confirmed, since the reporter provided a picture of the sleeve with a protruded pin.The device inspection revealed the following: both the sleeve and the knob were returned.They can be properly assembled without any issue.Contrary to what has been reported, the pin is properly inserted upon visual inspection of the sleeve.It was not coming loose or popping out.The pin was gently pushed with normal force from the inside in order to observe any potential loosening, but it remained properly positioned.The returned sleeve was tested with a compatible and fully functional gamma4 targeting arm sample.The returned sleeve 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.However, 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: the event can therefore be confirmed.The pin must have been pushed back to its proper position before being send to the inspection site.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.Since the sleeve was returned with a properly inserted pin and was tested to be fully functional, and in the absence of additional details, it is impossible to determine a root cause for the pin protrusion.Nevertheless, it is worth noting a non-conformity (nc) was triggered following previous similar events.Although no manufacturing issue was identified, a design change will be implemented to prevent such occurrence in the future.If more information is provided, the case will be reassessed.
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.

• Brand Name: TARGETING SLEEVE 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: 21566054
• Report Number: 0008031020-2025-00392
• Device Sequence Number: 9170599
• Product Code: HSB
• UDI-Device Identifier: 07613327479911
• UDI-Public: 07613327479911
• 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: 14200110
• 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: 03/10/2025
• 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