MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 1.55MM X 10MM TWIST DR,S; DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR

Catalog Number S-1510TD-G1

Device Problem Bent (1059)

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

Event Date 06/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the cutter device was bent while in use with the motor and attachment devices.There were no delays to the planned surgical procedure.It was unknown if a spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the tip of the cutter device was bent.It was determined that the cutter was examined and photographed using 40x magnification.Therefore, the reported condition was confirmed.It was determined that this was due to excessive lateral or side to side force.The assignable root cause was determined to be due to component damage caused by user error.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.55MM X 10MM TWIST DR,S
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 5741694
• MDR Text Key: 48769468
• Report Number: 1045834-2016-11999
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK113476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

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 Catalogue Number: S-1510TD-G1
• Device Lot Number: J153104773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 06/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1