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

Catalog Number 511.701

Device Problems Partial Blockage (1065); Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913); Naturally Worn (2988)

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

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device manufacture date: the device manufacture date is unavailable reporter¿s phone number: (b)(6).The manufacturing location is currently not available.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.The assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported from by (b)(6) that the compact air drive device had an undetermined malfunction.During the pre-repair diagnostics assessment, it was determined that the reverse locking mechanism was blocked and the gear was worn out.It was further determined that the device failed for general condition, check for air leak, check function of soft mode switch (safety system), check triggers for forward/reverse mode and for check for excessive noise.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any 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: COMPACT AIR DRIVE II (CAD II)
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; n/i; n/i
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; n/i; n/i
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6158541
• MDR Text Key: 62386562
• Report Number: 8030965-2016-15874
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.701
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Date Manufacturer Received: 11/24/2016
• 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