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	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The actual device was returned for evaluation.During evaluation of the device, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to premature wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
It was reported from (b)(6) that during service and evaluation, it was determined that the attachment device had a worn bearing.It was further determined that the device failed pretest for excessive vibration during the temperature and vibration assessment.It was noted in the service order that the device handpiece did not rotate while being used with three attachment devices.According to the reporter, when foot pedal was activated, the handpiece gave only quiet oscillated type of clogging sound, no rotational movement.After couple of seconds the console screen showed ¿booting view¿.Additionally, during testing the handpiece slightly warmed up.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 but was noted to have occurred in 2019.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: 9075495
• Report Number: 1045834-2019-54395
• Device Sequence Number: 16776598
• Product Code: HBC
• UDI-Device Identifier: 00845384016328
• UDI-Public: 00845384016328
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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: 08/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1