MAUDE Adverse Event Report: STRYKER GMBH INTERMEDIATE TARGETING SLEEVE GAMMA4; 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	03/19/2025
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: "before inserting the nail, the g4 intermediate device was attached to the main targeting device, and when checking to see if the drill tip would pass through the nail correctly, it was discovered that the drill would interfere with the nail.There was no alternative device.With the device lock loosened, the doctor performed the drilling and screw insertion, and the operation was completed.".
Additional Manufacturer Narrative
Corrections: please refer to sections d9 the device was returned for evaluation, and h6 (method, results and conclusion codes).The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the received sleeve is overall in good condition, there is no sign of wear or damage.It is worth noting that only the targeting sleeve was returned.The targeting arm and drill were not returned, and therefore could not be tested.The received sleeve was tested with fully functional targeting arm, drill and nail.The sleeve could be properly assembled with the targeting arm.When inserting the drill into the targeting sleeve, it could be passed through the nail without any misdrilling or interference with the holes borders.Therefore, the sleeve was assessed to be fully functional.Based on the investigation, the root cause could not be determined, as the event could be either user-related or related to the targeting arm and drill.The targeting arm as well as the drill must have been returned to perform a complete testing and determine a root cause for the reported event.However, the returned targeting sleeve was confirmed to be fully functional, and therefore did not contribute to the event.In summary, more detailed information about the complaint event as well as the additional used devices must be available in order to determine the root cause of the complaint 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 the targeting arm and drill are returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "before inserting the nail, the g4 intermediate device was attached to the main targeting device, and when checking to see if the drill tip would pass through the nail correctly, it was discovered that the drill would interfere with the nail.There was no alternative device.With the device lock loosened, the doctor performed the drilling and screw insertion, and the operation was completed.".

• Brand Name: INTERMEDIATE 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: 21847516
• Report Number: 0008031020-2025-00691
• Device Sequence Number: 15628129
• Product Code: HSB
• UDI-Device Identifier: 07613327591477
• UDI-Public: (01)07613327591477(10)K1A5E3A
• 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: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: KP505136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• 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