MAUDE Adverse Event Report: STRYKER GMBH G4 LAG SCREW D10,5XL85; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81600085S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "gamma 4 long nail was implanted, but the lag screw migrated postoperatively and the fracture reduction collapsed.Revision surgery is scheduled on (b)(6) 2023.".
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 : device is retained by the hospital.
Additional Manufacturer Narrative
The reported event could not be confirmed; but a displaced proximal bone fragment was confirmed on a provided x-ray copy.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.No indications of material, manufacturing or design related problems were found during the investigation.The device was not returned for investigation.4 x-ray-copies were provided which were forwarded for medical review.The summarized findings of the medical expert¿s: the event description could not be confirmed due to poor image quality.Focusing on the initial bone fracture; ¿it is very understandable though that this event could have occurred in this fracture type with the limited stabilization of this highly unstable fracture.The biomechanics of this fracture type were fully not addressed when only inserting the gamma nail.¿ if the device is returned or if any additional information is provided, we reserve the rights to reassess the investigation including root cause.The root cause of this event was regarded as user related.With given information a deficiency of the device was not verified.
Event or Problem Description
As reported: "gamma 4 long nail was implanted, but the lag screw migrated postoperatively and the fracture reduction collapsed.Revision surgery is scheduled on (b)(6) 2023.".

• Brand Name: G4 LAG SCREW D10,5XL85
• 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: 17939475
• Report Number: 0009610622-2023-00350
• Device Sequence Number: 6401045
• Product Code: HSB
• UDI-Device Identifier: 07613327510959
• UDI-Public: 07613327510959
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/01/2024

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: 81600085S
• Device Lot Number: K136CFD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2023
• 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 Sex: Unknown