MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS COMPACT SPEED REDUCER, 60:1; DRILLS, BURRS, TREPHINES & ACCESSORIES - COMPACT SPEED REDUCER

Catalog Number CSR60

Device Problems Bent (1059); Partial Blockage (1065); Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was duplicated and confirmed.The assignable root cause could not be determined.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported in the service order from (b)(6) that the compact speed reducer device was not rotating during a procedure.During service and repair evaluation, it was observed that the device gears were damaged, the reduction gear was blocked and the driving shaft was bent.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: COMPACT SPEED REDUCER, 60:1
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES - COMPACT SPEED REDUCER
• 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: 5736407
• MDR Text Key: 48731479
• Report Number: 1045834-2016-11985
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: PK042783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2016

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: CSR60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1