MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 8CM ANGLE ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number QD8

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).The actual device was returned for evaluation.The attachment device was evaluated and the reported condition that the device was not working was confirmed.An assessment was performed and it was observed that the device failed cutter insertion.Furthermore, it was determined that the bearings were worn out, loose and no longer in axial alignment which created a situation where the cutter was not able to be inserted and to pass through.The assignable root cause was determined to be due to worn out bearings from normal use and servicing over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the attachment device was not working.It was not reported if there was a delay in the procedure due to the event, or if a spare device was available for use.There was patient involvement reported.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 2017.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 8CM ANGLE ATTACHMENT
• Type of Device: MOTOR, DRILL, ELECTRIC - ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 7344927
• MDR Text Key: 102731564
• Report Number: 1045834-2018-50383
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 845384006626
• UDI-Public: (01)845384006626(11)141216
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K011444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: QD8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• Date Device Manufactured: 12/16/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1