MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC OSCILLATING MICRO SAW; DRILLS, BURRS, TREPHINES & ACCESSORIES - MICRO SAW

Model Number	O-SAW
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
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 was not functioning and had no rotation.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear.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 cutter device had separated into two parts when trying to 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 the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event is unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: OSCILLATING MICRO SAW
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES - MICRO SAW
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7552535
• Report Number: 1045834-2018-51019
• Device Sequence Number: 16187450
• Product Code: HBC
• UDI-Device Identifier: 00845384005612
• UDI-Public: (01)00845384005612(11)140723
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040076
• 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): 05/14/2018

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: O-SAW
• Device Catalogue Number: O-SAW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1