MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS MINIMAL ACCESS ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES - ATTACHMENT

Catalog Number MA-D20

Device Problem Temperature Problem (3022)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 from (b)(6) that the attachment device was heating up during operation.It was not reported if this event occurred during a surgical procedure.There were no reports of any delay in a surgical procedure or if a spare device was available for use.There was no patient involvement reported.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

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition that the device was heating up was confirmed.An assessment was performed on the device which found that the device was running over the temperature specification (117.9 degrees should be less than 110 degrees).During repair it was observed that the bearings were worn out, which caused the failure.The assignable root cause was determined to ne component damage caused by normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

During subsequent follow-up with the reporter, additional information was obtained.The reporter stated that the device heating up occurred during an initial spinal surgical procedure.It was reported that there was no delay in the procedure and a spare device was available for use.It was reported that surgery was completed successfully.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.It was reported that patient outcome was normal.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: MINIMAL ACCESS ATTACHMENT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES - 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: 5921506
• MDR Text Key: 53795706
• Report Number: 1045834-2016-12591
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042783
• 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,Followup,Followup
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MA-D20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2014
• 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