MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BEARING SLEEVE, 15CM CURVED; DRILLS, BURRS, TREPHINES & ACCESSORIES - ATTACHMENT

Model Number	MA-15C
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that 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 that during an unspecified surgical procedure, it was observed that the bearing sleeve device had an undetermined malfunction while in use with the cutter device.During in-house engineering evaluation, it was observed that the bearing sleeve device had exceeded the maximum allowable temperature.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: BEARING SLEEVE, 15CM CURVED
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES - ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7597670
• Report Number: 1045834-2018-51109
• Device Sequence Number: 16463166
• Product Code: HBE
• UDI-Device Identifier: 00845384004325
• UDI-Public: (01)00845384004325(11)160808
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2018

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: MA-15C
• Device Catalogue Number: MA-15C
• Device Lot Number: K053113819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Received by Manufacturer: 05/22/2018
• Initial 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