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

Catalog Number	05.001.045
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reporter¿s phone number was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported from (b)(6) that the burr attachment-short device was making a strange sound and became hot during use.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
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 reported condition was confirmed.It was determined that the bearing seized, jammed and was moving heavily.It was further determined that the attachment device was turning heavily.It was further determined that the device failed pretest for check of free moving.The assignable root cause was determined to be due wear from normal use servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BURR ATTACHMENT-SHORT FOR 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: 7491921
• Report Number: 8030965-2018-53587
• Device Sequence Number: 10812269
• Product Code: HWE
• UDI-Device Identifier: 07611819167919
• UDI-Public: (01)07611819167919
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K093361
• 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): 04/26/2018

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: 05.001.045
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1