MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 45DEG OSC DRILL ATCH MQC FOR PEN DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	05.001.033
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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.However, an assignable root cause could not be determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Event or Problem Description
It was reported by (b)(6) that during service and evaluation, it was determined that the oscillating drill attachment device was wobbling.It was noted in the service order that the device was not working while in use with the burr attachment device.This event did not occur during surgery.There was no patient involvement.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
Device evaluation update: upon further investigation, it was determined that the device failed pretest for check for free moving.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 45DEG OSC DRILL ATCH MQC 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: 7395886
• Report Number: 8030965-2018-52708
• Device Sequence Number: 1273798
• Product Code: HWE
• UDI-Device Identifier: 07611819167834
• UDI-Public: (01)07611819167834(11)070202
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 03/08/2018

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: 05.001.033
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1