MAUDE Adverse Event Report: SYNTHES GMBH; SCREW, FIXATION, BONE

Model Number	02.210.124
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During or procedure to remove hardware from right wrist, the head of a screw broke off while the surgeon was removing the screw.The surgeon was able to remove all parts and no parts were retained.This was confirmed by x-ray.

• Brand Name: NA
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; 1302 wrights lane e; west chester PA 19380
• MDR Report Key: 14799091
• Report Number: 14799091
• Device Sequence Number: 20098140
• Product Code: HWC
• UDI-Device Identifier: 10886982053015
• UDI-Public: (01)10886982053015
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/20/2022
• Report Date (Section F): 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.210.124
• Device Catalogue Number: 02210124
• Device Lot Number: 472P148
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 06/20/2022