MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 3MM FLUTED MATCHSTICK, 15CM; DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR

Model Number	MA15-8NS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacture date was unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported that during an unspecified surgical procedure, the burr device snapped.It was reported that the device was being used with a bearing sleeve device.It was not reported if there were no delays in the surgical procedure or whether a spare device was available for use.There was patient involvement.There were no 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.
Additional Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the reported condition that the cutter device had a broken tip was confirmed.The external features of the returned cutter were visually inspected and observed that the tip of the cutter was broken.The cutter was examined and photographed using 28x magnification.Based on the photographs taken the angle indicate that there was excessive force applied.The assignable root cause was determined to be due to excessive lateral or side to side force, which is user error.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 3MM FLUTED MATCHSTICK, 15CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7528659
• Report Number: 1045834-2018-50983
• Device Sequence Number: 2018877
• Product Code: HBE
• UDI-Device Identifier: 00845384004615
• UDI-Public: (01)00845384004615(10)M033128973
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K042783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

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: MA15-8NS
• Device Catalogue Number: MA15-8NS
• Device Lot Number: M033128973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 05/20/2018
• Supplement Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1