MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SCR/2.0X12MM BONE CROSS PIN; IMPLANT

Catalog Number	50-20412
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient developed osteomyelitis with a non union fracture and a screw was broken.
Additional Manufacturer Narrative
The reported infection could not be confirmed due to missing information; investigation of returned screws showed damage from high mechanical forces and instrument handling, with no device or manufacturing issues identified.Infection is a known ifu listed adverse effect.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.

• Brand Name: SCR/2.0X12MM BONE CROSS 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: 24629631
• Report Number: 0008010177-2026-00032
• Device Sequence Number: 8689300
• Product Code: JEY
• UDI-Device Identifier: 37613154184171
• UDI-Public: 37613154184171
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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: 50-20412
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Sex: Unknown