MAUDE Adverse Event Report: STRYKER GMBH RC LAG SCREW GAMMA4 Ø10.5X85MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660085S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The gamma 4 u blade inserted using hammering sensation by surgeon results in perforation of femoral head.
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.An inspection could not be performed because the item is still implanted.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.In the case presented a patient (no data available) was treated with above implant on (b)(6) 2024.It was reported that the femoral head was perforated (cut through) when the gamma4 u-blade was hammered in.The u-blade was inserted using the hammering sensation and confirmation with lateral view of x-ray as indicators but confirmed perforation of the femoral head in the x-rays after insertion of the u-blade.The u-blade was temporarily removed, the set screw was loosened, and the lag screw was returned to the appropriate position.Further information was not given.The process of u-blade insertion is clearly described in the labelling.Careful hammer strokes shall be applied to the strike plate of the rc inserter in order to proceed the u-blade to its final position.Even if the patient has very poor bone condition significant stresses have to be applied on the system to have the u-blade to cut through the femur head.However, the situation was solved in the same surgery by the same surgery within 10 minutes which is in an acceptable rage of delay.The event was caused by the user while applying significant load on the implants and bone.With available information a deficiency of the product was not verified.
Event or Problem Description
The gamma 4 u blade inserted using hammering sensation by surgeon results in perforation of femoral head.

• Brand Name: RC LAG SCREW GAMMA4 Ø10.5X85MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19803988
• Report Number: 0009610622-2024-00715
• Device Sequence Number: 17988667
• Product Code: HSB
• UDI-Device Identifier: 07613327591798
• UDI-Public: (01)07613327591798(17)3400430(10)K1B280F
• 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): 11/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 81660085S
• Device Lot Number: K1B280F
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown