MAUDE Adverse Event Report: SYNTHES (U.S.A.) LP 2.5 MM EXTRA LONG GOLD DRILL BIT; INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED ACCESSORY/ATTACHMENT

Model Number 310.23

Device Problem Break (1069)

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

Event Date 07/31/2020

Event Type  malfunction  

Event Description

A broken drill bit approximately 2.2 cm long broke off during surgery.

• Brand Name: 2.5 MM EXTRA LONG GOLD DRILL BIT
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES (U.S.A.) LP; 1210 ward ave; west chester PA 19380
• MDR Report Key: 10424760
• MDR Text Key: 203487846
• Report Number: 10424760
• Device Sequence Number: 1
• Product Code: HSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/12/2020

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: Health Professional
• Device Model Number: 310.23
• Device Catalogue Number: 31023
• Device Lot Number: H109521
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2020
• Date Report to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18250 DA