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

Catalog Number B-BLUE-S

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition of damaged bearings was confirmed.An assessment was performed which found that the attachment was functional, but the bearing was damaged due to normal wear causing an increase of the heat up to 131 °f (specification = 118°f).It was also noted that the blue detection ring is completely removed and the labelling was not visible.It was determined that the attachment device was wrongly reprocessed with inappropriate and/or aggressive cleaners.The assignable root cause was determined to be due to wear from normal use and servicing over time, and improper reprocessing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported from (b)(6) that the attachment device had damaged bearings.During service and evaluation, it was found that the attachment device was functional, but the bearing is damaged causing an increase of the heat up to 131 °f.It was also observed that the blue detection ring was completely removed, and the labeling was not visible.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted 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: 6178247
• MDR Text Key: 62532296
• Report Number: 1045834-2016-13433
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K974025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2016

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-BLUE-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2000
• 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