MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BEARING SLEEVE, 15CM CURVED; DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)

Model Number	MA-15C
Medical Device Problem Code	Overheating of Device (1437)
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
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 the bearing sleeve attachment device started heating up and had bad bearings.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 the event was not reported, however it was noted that the event occurred in 2018.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 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.
Additional Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device; and determined that the device passed all operational specifications and identified no failure.Therefore, the reported condition was not duplicated and confirmed and an assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BEARING SLEEVE, 15CM CURVED
• Common Device Name: DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7677262
• Report Number: 1045834-2018-51288
• Device Sequence Number: 16532640
• Product Code: HBE
• UDI-Device Identifier: 00845384004325
• UDI-Public: (01)00845384004325(11)090306(10)B463014489
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 06/25/2018

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: B463014489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/02/2018; 09/12/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/23/2018; 09/18/2018
• Patient Sequence Number: 1