MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 11.25CM ATTACHMENT, BM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT

Catalog Number B-BLUE-S_LL

Device Problem Overheating of Device (1437)

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

Event Date 05/05/2014

Event Type  malfunction  

Event Description

It was reported that during pre-surgery, it was observed that the attachment had heat.There were no delays to the planned surgical procedure as an identical 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

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that a cutter could not be inserted into the device due to worn bearings.It was determined that worn and loose bearings usually create a situation where the cutter is not able to be inserted due to bearings that are no longer in axial alignment.It was determined this would have caused heat if a cutter was able to be inserted and the device was run.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear and servicing over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• Brand Name: 11.25CM ATTACHMENT, BM
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT
• 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: 4115943
• MDR Text Key: 16451645
• Report Number: 1045834-2014-12954
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK974025
• 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: 05/05/2014

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: B-BLUE-S_LL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2014
• Initial Date Manufacturer Received: 05/13/2014
• Initial Date FDA Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1