MAUDE Adverse Event Report: SYNTHES GMBH; PLIERS, SURGICAL

Model Number	359.204
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This pair of pliers broke while attempting to remove a nail from the patient's leg.The tip fragmented into multiple pieces.One fragment of the pliers was found in the suction cannister, a second fragment was found and removed following an xray to check for additional fragments.

• Brand Name: NA
• Common Device Name: PLIERS, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; 1302 wrights lane e; west chester PA 19380
• MDR Report Key: 20577341
• Report Number: 20577341
• Device Sequence Number: 8827601
• Product Code: HTC
• UDI-Device Identifier: 07611819093041
• UDI-Public: (01)07611819093041(10)6453P31
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/06/2024
• Report Date (Section F): 09/06/2024

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
• Device Model Number: 359.204
• Device Catalogue Number: 359204
• Device Lot Number: 6453P31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 10/31/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• 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 Age: 11 YR
• Patient Sex: Male
• Patient Weight: 44 KG
• Date Report Sent to FDA: 09/06/2024