MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 12.6CM TAPERED ATTACHMENT, BLACK MAX; BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT

Catalog Number B-TURQ-L

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition that the device was broken was confirmed.An assessment was performed on the device which found that the device failed temperature assessment, overheating to 120 degrees.It was determined that the bearings are worn out/damaged.Corrosion was also found.It was further determined that the failure was caused by worn out/damaged bearings.The assignable root cause was determined to be component damage due to normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that the attachment device was broken.During in-house engineering evaluation it was found that the device failed temperature assessment.It was also noted that the bearings were worn out and damaged.It was not reported if this event occurred during a surgical procedure.It was not reported if there was a delay in a procedure due to the event.It was not reported if a spare device was available for use.There was no patient involvement.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.

• Brand Name: 12.6CM TAPERED ATTACHMENT, BLACK MAX
• 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: 6251230
• MDR Text Key: 64891960
• Report Number: 1045834-2017-10111
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2016

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: B-TURQ-L
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2009
• 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