MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC OTOLOGIC CURVED MICRO ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	OCM
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
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 additional information should become available, a supplemental medwatch report will be submitted accordingly.
Event or Problem Description
It was reported that during service and repair pre-testing, it was determined that the attachment device was overheating.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 report will be submitted accordingly.
Additional Manufacturer Narrative
Device manufacture date: the device manufacture date was incorrectly documented in the initial report.The device manufacture date has been updated from (b)(4) 2010 to (b)(4) 2014.The udi has been updated accordingly.The actual device was returned for evaluation.The device was evaluated, and the reported condition was confirmed.A visual and functional assessment was performed which found that the device was overheating.During repair, it was observed that the bearings were worn out and damaged.The assignable root cause was determined to be due to normal wear out from use.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: OTOLOGIC CURVED MICRO ATTACHMENT
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7741902
• Report Number: 1045834-2018-51400
• Device Sequence Number: 1365218
• Product Code: ERL
• UDI-Device Identifier: 00845384017493
• UDI-Public: (01)00845384017493(11)100706
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018

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: OCM
• Device Catalogue Number: OCM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1