MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 11CM ANGLE ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number QD11

Device Problems Vibration (1674); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.It was determined that there were damaged components, the bearings were damaged.The assignable root cause was determined to be due to wear from normal use and servicing.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Initial reporter number: (b)(6).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during service and evaluation, it was observed that the attachment device had damaged bearings and "strong" vibration during entry test and the bushing was defective.It was noted on the service order that it was impossible to insert the device into the motor device.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 this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 11CM ANGLE ATTACHMENT
• Type of Device: MOTOR, DRILL, ELECTRIC - ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 5417441
• MDR Text Key: 38233865
• Report Number: 1045834-2016-10359
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: QD11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1