MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 5CM HEAVY DUTY SHORT ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number	SHORT-HD
Medical Device Problem Codes	Vibration (1674); Excessive Heating (4030)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The assignable root cause was traced to component failure due to faulty parts.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 repair/pre-testing, it was observed that the attachment device bearing was worn and the triangle symbol was missing.The device also failed pretests for preload, vibration and temperature assessment.The event was not related to surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 5CM HEAVY DUTY SHORT 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: 9660002
• Report Number: 1045834-2020-00192
• Device Sequence Number: 3319969
• Product Code: HBC
• UDI-Device Identifier: 00845384008804
• UDI-Public: 845384008804
• 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): 01/08/2020

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: SHORT-HD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1