MAUDE Adverse Event Report: SYNTHES (U.S.A.) LP; FORCEPS

Model Number 399.124

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2020

Event Type  malfunction  

Event Description

Surgical bone clamp broke during surgery.Broken piece found in its entirety and matched to instrument.No evidence that foreign object was left within patient.Surgeon, peri-op team, manager and sterile processing/distribution made aware.

• Brand Name: NA
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNTHES (U.S.A.) LP; 1301 goshen pkwy; west chester PA 19380
• MDR Report Key: 10114046
• MDR Text Key: 193628159
• Report Number: 10114046
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/28/2020

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 Operator: No Information
• Device Model Number: 399.124
• Device Catalogue Number: 399124
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2020
• Type of Device Usage: N
• Patient Sequence Number: 1