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 Break (1069); Positioning Problem (3009)

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

Event Type  malfunction  

Event Description

It was reported that the perforator driver device was broken.During in-house engineering evaluation, it was observed the device would not rotate.It was not reported that the malfunction occurred during surgery.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There were no reports of injuries, medical interventions or prolonged hospitalizations.The date of the event was unknown.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.Visual and functional assessments were performed and found that the device would not rotate.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to immersion during cleaning, which is misuse, abuse and possibly 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: 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: 3950994
• MDR Text Key: 4602097
• Report Number: 1045834-2014-12524
• 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: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CSR60_LL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2014
• Date Manufacturer Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1