MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 11.25CM ATTACHMENT, BLACK MAX; BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT

Catalog Number B-BLUE-S

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.However, since the investigation is still on-going, the assignable root cause could not be determined at this time.Once investigation has been completed, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).

Event Description

It was reported that during service and repair pretesting, the attachment device was overheating and failed the pre-load test.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 the event was not reported, however, it was reported that the event occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The actual device was returned for evaluation.During repair, it was determined that one of the bearings of the attachment device was broken, causing the device to overheat and fail the pre-load test, and the nose cone had scratches on it.It was further determined that the device failed pretest for temperature assessment, and visual assessment.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 11.25CM ATTACHMENT, BLACK MAX
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8859933
• MDR Text Key: 161702396
• Report Number: 1045834-2019-54231
• Device Sequence Number: 1
• Product Code: GFF
• UDI-Device Identifier: 00845384000518
• UDI-Public: 845384000518
• Combination Product (y/n): N
• PMA/PMN Number: K974025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• 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: 03/03/2017
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1