MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SCR/2.0X10MM MP BONE CRSS PIN; IMPLANT

Catalog Number	50-20710
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	04/24/2025
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 right total joint was removed due to infection.
Additional Manufacturer Narrative
Additional information: h6.The reported incident could not be confirmed because insufficient information was provided.Despite repeated requests, no additional information could be obtained from the surgeon to further clarify the incident or the product stress conditions.An extended investigation revealed no problems related to the device or manufacturing, confirmed the correct cleaning and sterilization instructions for the non-sterile devices, and determined that infections are a known side effect listed in the instructions for use.Based on the investigation, there are no indications of a malfunctioning product or problems related to design, material, or manufacturing.Therefore, no corrective and/or preventive measures are considered necessary at this time.
Event or Problem Description
No new information.

• Brand Name: SCR/2.0X10MM MP BONE CRSS PIN
• 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: 23816127
• Report Number: 0008010177-2025-00164
• Device Sequence Number: 21333831
• Product Code: JEY
• UDI-Device Identifier: 34546540602580
• UDI-Public: 34546540602580
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 02/12/2026

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
• Device Catalogue Number: 50-20710
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/12/2026
• 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