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

Catalog Number QD8

Device Problems Break (1069); Vibration (1674); Failure of Device to Self-Test (2937); Naturally Worn (2988)

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

Event Date 07/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The 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.The assignable root cause was determined to be due to strain/wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported by (b)(6) that during service and evaluation, it was observed that the angle attachment device had a damaged component: bearings.It was noted that the device had worn out bearings and the color coding was out of specification.It was further determined that the device failed the following at pretest: visual assessment, thimble lock operation (falls under locking mechanism not functioning) and vibration (falls under vibration).It was not reported if this event occurred during a surgical procedure.It was reported that there was no delay in a procedure due to the event.It was not reported if a spare device was available for use.There was no patient involvement.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 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: 5928544
• MDR Text Key: 54051227
• Report Number: 1045834-2016-12625
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K011444
• 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
• Report Date: 07/29/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: QD8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2011
• 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