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

Catalog Number QD11

Device Problems Loose or Intermittent Connection (1371); Component Missing (2306); Defective Device (2588); Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter¿s phone 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 by (b)(6) that during service and evaluation, it was observed that the angle attachment device had missing components - roll pins.It was further determined that the tool was not detachable, bearing was defective, sleeve for coupling was loose (not glued), various parts were worn and screw and tip were loose.It was noted in the service order that no rotation was possible on the 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.

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 the device had roll pin missing, defective bearings, loose coupling, screw and tip.The assignable root cause was due to manufacturing and process error.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 5392710
• MDR Text Key: 37091942
• Report Number: 1045834-2016-10254
• 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: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• 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: 01/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2012
• 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