MAUDE Adverse Event Report: STRYKER GMBH G4 LAG SCREW D10,5XL95; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81600095S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon implanted a gamma4 intermediate nail in combination with an rc lag screw and with use of the anti-rotation clip for treatment of an unstable fracture in the trochanteric region.He took out the short nail and put in a longer nail.Following information was received from the sales rep: "the previous nail was a stryker gamma4 nail that was incorrectly positioned and cut-out.The surgeon elected to revise it and added a longer nail.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : not returned.
Event or Problem Description
It was reported that the surgeon implanted a gamma4 intermediate nail in combination with an rc lag screw and with use of the anti-rotation clip for treatment of an unstable fracture in the trochanteric region.He took out the short nail and put in a longer nail.Following information was received from the sales rep: "the previous nail was a stryker gamma4 nail that was incorrectly positioned and cut-out.The surgeon elected to revise it and added a longer nail.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.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.The importance of correct placement of lag screw and set screw is pointed out in the labelling.The same is valid for securing the lag screw with the set screw.No indications of material, manufacturing or design related problems were found during the investigation.In the case presented a patient had bee revised with a gamma4 intertrochanteric nail following an event of incorrectly positioned trochanteric nail and cut-out.The affected product and / or medical records were not provided.It could not be determined if the event covered a real cut-out (bone fragments collapsing over the implant) or if the event refers to a medialization of the lag screw.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A real root caused could not be determined.If more information or the item itself is provided, we reserve the rights to reopen the case for root cause determination.With available information a product deficiency was not verified.

• Brand Name: G4 LAG SCREW D10,5XL95
• 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: 18353935
• Report Number: 0009610622-2023-00456
• Device Sequence Number: 15101682
• Product Code: HSB
• UDI-Device Identifier: 07613327511017
• UDI-Public: 07613327511017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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: Lay User/Patient
• Device Catalogue Number: 81600095S
• Device Lot Number: K158FB6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2023
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female