MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PLT/6HL/L/8MM ADVC 100D RT STD; IMPLANT

Catalog Number	55-06765
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Event or Problem Description
It was reported that the device may have broken after surgery.
Additional Manufacturer Narrative
Correction: b1 update: b5, h6 the reported event is considered as confirmed.The implanted plate was positioned pointing to the left side, contrary to the manufacturer's instructions, which specify it should point to the right.This off-label use may have compromised the plate's integrity, especially if it was implanted upside down, as improper screw insertion can damage the plate and reduce its stability.This likely contributed to the plate's breakage observed in the follow-up x-ray.The use of the cutter in this context is also considered off-label.Based on the investigation, there is no indication for an incorrectly working product or any design, material, or manufacturing-related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.
Event or Problem Description
It was reported that the device has been broken after surgery.The plate was used as off-label use.

• Brand Name: PLT/6HL/L/8MM ADVC 100D RT STD
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: elena drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 20479382
• Report Number: 0008010177-2024-00110
• Device Sequence Number: 12863400
• Product Code: JEY
• UDI-Device Identifier: 04546540366047
• UDI-Public: 04546540366047
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022185
• 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): 05/08/2025

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: 55-06765
• Device Lot Number: 1000508211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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