MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø13X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35253380S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.H3 other text: device disposition is unknown.
Event or Problem Description
As reported: "gamma 3 implanted 16 months ago and 100 days later the implant broke.Screws at the bottom broke and nail also broke by the point where the lag screw is implanted.Entire construct was revised and patient experienced a similar event 100 days later.".
Additional Manufacturer Narrative
The reported event could be confirmed based on details provided, only.Images available revealed a broken nail.Due to missing device a physical evaluation was impossible and further technical statement could not be given.In the case presented a 61-year-old male patient, at time of reported event, was primarily treated with a long nail kit r1.5, ti, left gamma3 013x380mm x 125 on (b)(6) 2022 and revised on (b)(6) 2023 by a long nail kit r1.5, ti, left gamma3 015x400mm x 125 during a 1st revision.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 case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "gamma 3 implanted 16 months ago and 100 days later the implant broke.Screws at the bottom broke and nail also broke by the point where the lag screw is implanted.Entire construct was revised and patient experienced a similar event 100 days later.".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø13X380MM X 125°
• 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: 19038219
• Report Number: 0009610622-2024-00126
• Device Sequence Number: 6992361
• Product Code: HSB
• UDI-Device Identifier: 04546540409928
• UDI-Public: 04546540409928
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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 Expiration Date: 06/30/2025
• Device Catalogue Number: 35253380S
• Device Lot Number: K0DD2F3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 77 KG