MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 8 CM HEAVY DUTY MEDIUM ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number	MEDIUM-HD-G1
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This device was returned for evaluation; however, during pre-repair assessment, it was determined that the device passed all operational specifications and no failure was identified.Therefore, the reported condition was not confirmed and an assignable root cause was not determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
It was reported that the attachment device overheated prior to surgery.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 will be submitted accordingly.

• Brand Name: 8 CM HEAVY DUTY MEDIUM ATTACHMENT
• 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: 9552754
• Report Number: 1045834-2020-00021
• Device Sequence Number: 19321121
• Product Code: HBC
• UDI-Device Identifier: 00845384016328
• UDI-Public: 845384016328
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K011444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

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 Catalogue Number: MEDIUM-HD-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1