MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 11CM LONG ATTACH; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number	LONG-G1
Medical Device Problem Code	Material Fragmentation (1261)
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
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the nose tube of the device was chipped and damaged.It was further determined that the device failed pretest for visual assessment.The assignable root cause was determined to be traced to user, which is user error.Udi: (b)(4).
Event or Problem Description
It was reported that during service and evaluation, it was observed that the nose tube of the attachment device was chipped.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: 11CM LONG 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: 10197741
• Report Number: 1045834-2020-01002
• Device Sequence Number: 3408247
• Product Code: HBC
• UDI-Device Identifier: 00845384016335
• UDI-Public: 845384016335
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

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: LONG-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1