MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SCR/2.3X8MM LCKNG CROSS PIN; IMPLANT

Catalog Number	50-23508
Medical Device Problem Codes	Fracture (1260); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one year after the surgery, the screws were broken.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Additional Manufacturer Narrative
Additional information: h6 correction: d9, h3 it was determined after receiving further clarification from the customer and the log files from the device, this event for this product was not a reportable event per cfr 21, part 803.This supplemental is being filed to identify an mdr was not required for this event.Device evaluation: follow-up report submitted to document device evaluation results.The inspection of the returned plate and screws indicated that the intact screws were suitable for use with the plate and did not contribute to its breakage.Therefore, they were classified as concomitants.
Event or Problem Description
No new information.

• Brand Name: SCR/2.3X8MM LCKNG 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: 20885535
• Report Number: 0008010177-2024-00134
• Device Sequence Number: 21093350
• Product Code: JEY
• UDI-Device Identifier: 37613154184515
• UDI-Public: 37613154184515
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/11/2025

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
• Device Catalogue Number: 50-23508
• 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: 11/25/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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