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

Catalog Number B-TURQ-L

Device Problems Overheating of Device (1437); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition that the insides were worn and slipping was confirmed.An assessment was performed on the device which found that the unit reflected heat with a reading of 126.7 degrees fahrenheit which is greater than manufacturers' specification (specified reading is less than or equal to 118 degrees fahrenheit).It was also found that the attachment had excessive external wear and was cosmetically unacceptable.It was determined that the failure was caused by worn out bearings.The assignable root cause was determined to be due to wear from 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 "insides" were worn and slipping on the attachment device.During in-house evaluation, it was found that the unit reflected heat, had excessive external wear, and was cosmetically unacceptable.It was not reported if the device was used in surgery.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was reported there was no patient involvement.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.The exact date of the event was not reported.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 ATTACH, 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: 5646481
• MDR Text Key: 45045339
• Report Number: 1045834-2016-11698
• 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: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/03/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2014
• 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