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

Catalog Number	81600085S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	12/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition is unknown.
Event or Problem Description
Clinical study pegasus subject (b)(6).Xray show hardware migration/cut-out.Hardware was removed (b)(6) 2023.Update 01/23/2024 - nonunion, left intertrochanteric fracture.Cut out of gamma nail, left hip with hardware pain.
Event or Problem Description
Clinical study pegasus subject (b)(6).Xray show hardware migration/cut-out hardware was removed (b)(6) 2023.Update 01/23/2024 - nonunion, left intertrochanteric fracture.Cut out of gamma nail, left hip with hardware pain.
Additional Manufacturer Narrative
Please note correction to section h6 (results and conclusion codes).The reported event could be confirmed based on the images received.The device was not returned.However, post-operative x-rays were received.The reported event could be confirmed as the lag screw cut-out after approx.3 months of implantation was clearly visible.The x-rays were reviewed by a medical expert, who stated: "this would be cut-out.I do not see migration.The implant did not move, the bone sank over/ on the lag screw.The screw did not move in comparison to the nail, so the implant itself did not move." any medical error is "impossible to determine without the trauma x-rays and the x-rays taken directly after the procedure." based on investigation, the root cause was attributed to a bone condition related issue.The failure was caused by the intertochanteric fracture and the bone non-union, which caused the sinking of the bone over the lag screw.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• 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: 18563160
• Report Number: 0009610622-2024-00041
• Device Sequence Number: 12477166
• Product Code: HSB
• UDI-Device Identifier: 07613327510959
• UDI-Public: 07613327510959
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 81600085S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 68 KG