MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BURR ATTACHMENT-LONG-ANGLED F/PEN DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	05.001.050
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device had heat.Therefore, the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to maintenance, which is user error/ misuse/ abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi: (b)(4).
Event or Problem Description
It was reported from the (b)(6) that the moving parts of the attachment device were moving smoothly, and the device was generating heat.It was further determined that the device failed pretest for check of free movement.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.
Additional Manufacturer Narrative
H10: 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.Correction b5: it was inadvertently reported in the initial medwatch report that the moving parts of the attachment device were moving smoothly.Upon further review of the device evaluation, it was determined that the moving parts of the device were not moving smoothly.H6: it was reported in the initial medwatch report that the root cause of the reported failure was determined to be traced to maintenance, which is user error/misuse/abuse.Upon further review of the device evaluation, it was determined that the assignable root cause was traced to component failure.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: BURR ATTACHMENT-LONG-ANGLED F/PEN DRIVE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9440498
• Report Number: 8030965-2019-70894
• Device Sequence Number: 2335612
• Product Code: HWE
• UDI-Device Identifier: 07611819167957
• UDI-Public: 07611819167957
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 05.001.050
• Device Lot Number: 7668936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 12/22/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1