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

Model Number	R-SAW
Medical Device Problem Codes	Overheating of Device (1437); Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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 that during a teaching procedure in a cadaver lab, it was observed that the reciprocating saw device was making a broken sound and had excessive vibration.It was further reported that the device became extremely hot with smoke and metal shavings were coming out of it.It was confirmed that the event did not occur during a surgical procedure.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition of the device making a broken sound and becoming extremely hot with smoke and metal shavings coming out was not confirmed.Therefore, an assignable root cause was not determined.However, the reported condition of the device having excessive vibration was confirmed.A visual and functional assessment was performed on the device which found that the internal parts were worn out and had corrosion, causing the vibration.It was determined that the issue was consistent with normal wear over time.The assignable root cause was determined to be due to normal wear out from use.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RECIPROCATING 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: 7075222
• Report Number: 1045834-2017-50087
• Device Sequence Number: 1357748
• Product Code: HBE
• UDI-Device Identifier: 00845384007173
• UDI-Public: (01)00845384007173(11)060517
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2017

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: R-SAW
• Device Catalogue Number: R-SAW
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Initial Date Received by Manufacturer: 11/04/2017
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1