MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS CAD II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 511.701

Device Problems Incorrect Or Inadequate Test Results (2456); Defective Device (2588); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Date 09/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 improper handling, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported by (b)(6) that during service and evaluation, it was observed that the coupling tool side on the compact air drive was not functioning and defective.It was also noted that the handpiece had a worn out softmode switch, gear, gear shaft, coupling shaft and bearings.It was further noted that the device failed pre-test for general condition and function of soft mode switch.This event did not occur during surgery.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: CAD II
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; ni
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; ni; ni
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6038189
• MDR Text Key: 57872489
• Report Number: 8030965-2016-15224
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• 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: 09/05/2016

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: 511.701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2016
• Initial Date FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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