MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS PERFORATOR DRIVER W/HUDSON END; DRILLS, BURRS, TREPHINES & ACCESSORIES - COMPACT SPEED REDUCER

Catalog Number CSR60_LL

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2015

Event Type  malfunction  

Event Description

It was reported that during testing, it was discovered that the compact speed reducer device would not turn.There was no patient involvement reported.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 device had no rotation.Therefore, the reported condition was confirmed.It was determined that this was due to a worn out and damaged gearbox.The assignable root cause was determined to be due to normal wear over time.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: PERFORATOR DRIVER W/HUDSON END
• 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: 4848804
• MDR Text Key: 19742265
• Report Number: 1045834-2015-11340
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CSR60_LL
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2015
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1