MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - RC LAG SCREW D10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660090S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "when inserting the u-blade with hammer, the lag screw went together with the u-blade just to the tip of the femoral head.The u- lag screw was replaced to the 85mm one.".
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
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: the complete rc lag screw including u-blade and end cap were returned for evaluation.The reported catalog and lot numbers could be confirmed based on the laser marking.The lag screw and u-blade could be disassembled and were found to be in good condition overall ¿ there is no deformation or significant damage (slight marks can be visible, most likely from the insertion attempts).A functional inspection with a compatible and functional gamma4 nail was conducted.The rc lag screw was able to be inserted through the nail as intended, without any difficulty.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 investigation, the root cause was attributed to a user related issue.The event was caused by inadequate insertion of the rc lag screw, most likely due to excessive force applied during hammering.In this relation, the operative technique emphasizes that great caution must be advised during the hammering step of the rc lag screw: the insertion is done by hand until the u-blade spreads open and starts to contact the surrounding bone.At this point, the u-blade should be approximately 25mm away from its final position.Use the slotted hammer and apply careful hammer strokes to the strike plate of the rc inserter in order to insert the u-blade until its final position.Take care during u-blade insertion with the hammer to avoid implant or bone damage.Observe the indicator rings of the rc guide and rc inserter to stop hammering when the u-blade is in its final position.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "when inserting the u-blade with hammer, the lag screw went together with the u-blade just to the tip of the femoral head.The u- lag screw was replaced to the 85mm one.".

• Brand Name: GAMMA4 - RC LAG SCREW D10.5X90MM
• 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: 22441502
• Report Number: 0009610622-2025-00013
• Device Sequence Number: 18010817
• Product Code: HSB
• UDI-Device Identifier: 07613327591804
• UDI-Public: (01)07613327591804(17)341130(10)K0FC293
• 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): 08/21/2025

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: 81660090S
• Device Lot Number: K0FC293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown