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

Catalog Number	LONG-HD
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the cutter device could not be inserted easily, the bearing was contaminated, and the device was vibrating too much.It was further determined that the device failed pretest for vibration assessment.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use over time.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use over time.(b)(4).
Event or Problem Description
It was reported that during testing it was observed that the bearing of the long attachment device was broken.During in-house engineering evaluation it was observed that the device was vibrating too much.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: 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: 8767220
• Report Number: 1045834-2019-53968
• Device Sequence Number: 2091964
• Product Code: HBC
• UDI-Device Identifier: 00845384003595
• UDI-Public: 845384003595
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/11/2019

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: LONG-HD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1