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

Catalog Number	O-SAW
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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
Udi: (b)(4).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The device is being further investigated.Once the investigation has been completed, a supplemental medwatch will be submitted.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
It was reported from (b)(6) that during pre-testing, it was observed that the oscillating saw device fell apart.The event was not related to surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
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.The date device returned to manufacturer was documented as november 18th, 2019 in the initial report.This has been corrected to november 12th, 2019.If additional information should become available, a supplemental medwatch report will be submitted accordingly.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device fell apart.Therefore, the reported condition was confirmed.The assignable root cause was traced to component failure.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: 9420725
• Report Number: 1045834-2019-54984
• Device Sequence Number: 11190436
• Product Code: HBE
• UDI-Device Identifier: 00845384005612
• UDI-Public: 845384005612
• 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,Followup
• Report Date (Section B): 11/18/2019

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: O-SAW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1