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

Catalog Number	MEDIUM-HD
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device had vibration.Therefore, the reported condition that the device had an undetermined malfunction was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to normal wear.Udi: (b)(4).
Event or Problem Description
It was reported from switzerland that during service and evaluation, it was determined that the attachment device had missing labeling, the bearing was worn, and the device had vibration and component damage.It was further determined that the device failed pretest for labeling assessment, nose cone verification, and vibration verification.It was noted in the service order that the device had an undetermined malfunction.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 the event was not reported, however, it was reported that the event occurred in 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 8CM HEAVY DUTY MEDIUM ATTACH
• 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: 10856162
• Report Number: 1045834-2020-01908
• Device Sequence Number: 14180174
• Product Code: HBC
• UDI-Device Identifier: 00845384004905
• UDI-Public: 845384004905
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K011444
• 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): 10/14/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1