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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Device evaluation: the actual device was returned for evaluation.The device was evaluated, and the reported condition was confirmed.A visual and functional assessment was performed on the device which determined that the device came in disassembled.During repair, it was observed that there were teeth marks at the nose cone (failed pretest for visual assessment) and the loctite had broken apart in the secondary lock protection.The assignable root cause was determined to be due user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Event or Problem Description
It was reported that during pre-surgery it was discovered that the attachment device was broken.During in-house engineering evaluation, it was observed that there were teeth marks in the nose cone (failed pretest for visual assessment) and the loctite had broken apart at the secondary lock protection.There were no delays to the surgical procedure as a spare device was available for use.There was no patient involvement reported.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 report 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: 8365817
• Report Number: 1045834-2019-52951
• Device Sequence Number: 2306783
• Product Code: HBC
• UDI-Device Identifier: 00845384004905
• UDI-Public: 845384004905
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/08/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1