MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 12.4CM HEAVY DUTY LONG ATTCH; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Model Number	LONG-HD
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2018
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 during inspection, it was observed that the attachment device was running hot.This event did not occur during surgery.There was no patient involvement.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 report will be submitted accordingly.

• Brand Name: 12.4CM HEAVY DUTY LONG ATTCH
• Common Device Name: MOTOR, DRILL, ELECTRIC - ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7498151
• Report Number: 1045834-2018-50951
• Device Sequence Number: 1949377
• Product Code: HBC
• UDI-Device Identifier: 00845384003595
• UDI-Public: (01)00845384003595
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K011444
• 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
• Report Date (Section B): 04/24/2018

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: LONG-HD
• Device Catalogue Number: LONG-HD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1