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

Model Number	05.001.038
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2018
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 passed all operational specifications and no failure was identified.Therefore, the reported condition was not confirmed and an assignable root cause was not determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
It was reported from (b)(6) that the oscillating saw attachment device had a lot of vibration which was out of the ordinary.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.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: OSCILLATING SAW ATTACHMENT 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: 7681493
• Report Number: 8030965-2018-54962
• Device Sequence Number: 1398934
• Product Code: HWE
• UDI-Device Identifier: 10886982128539
• UDI-Public: (01)10886982128539(11)110520(10)3792179
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 06/25/2018

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 Model Number: 05.001.038
• Device Catalogue Number: 05.001.038
• Device Lot Number: 3792179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1