MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC COMPACT AIR DRIVE II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 511.701

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

Reporter¿s phone number was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from (b)(6) that during a radial neurolysis and cemented osteosynthesis surgical procedure, it was observed that the compact air drive did not work and could not be used for the procedure while in use with an air hose device.According to the report, an incision was made to remove a tumor on the femur before using the devices.It was reported that the patient was bleeding a lot from the incision but did not require blood transfusion.It was reported that the compact air drive device was dead and did not work at all when tested with other air hose devices while the air hose device was working great with other compact air drive devices.It was reported that there was a delay of half hour to one hour delay in the surgical procedure to get a replacement device.It was reported that the surgeon used a manual technique to complete the procedure successfully.There were no injuries, medical intervention or prolonged hospitalization.The patient's status post-op was stable.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Adverse event box was not checked in error during initial medwatch submission.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the device had a blocked air motor and failed pre-test for air hose coupling, function of soft mode switch, triggers for forward and reverse mode, power with the test bench and starting behavior.It was further determined that the motor was seized, jammed and moving heavily.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: COMPACT AIR DRIVE II
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7406194
• MDR Text Key: 104670181
• Report Number: 8030965-2018-52848
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819085268
• UDI-Public: (01)7611819085268(11)120404(21)
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/27/2018
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 04/24/2018; 04/27/2018; 07/17/2018
• Supplement Dates FDA Received: 04/24/2018; 05/02/2018; 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1