MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BLACKMAX; INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC - HANDPIECE

Catalog Number B-BLACK

Device Problem Air Leak (1008)

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

Event Date 02/21/2014

Event Type  malfunction  

Event Description

This is report 1 of 2 of the same event.It was reported that during an anterior/posterior spine surgery, the motor device had a "possible air leak while in use with an attachment".The reporter was "not sure if there was a leak in the hose or if the attachment was the problem".There was no delay to the scheduled surgical procedure.An identical spare device was available for use.There were no reports of injuries, adverse events or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.Therefore, an assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BLACKMAX
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC - HANDPIECE
• 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: 3664659
• MDR Text Key: 4316629
• Report Number: 1045834-2014-11540
• Device Sequence Number: 1
• Product Code: HSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK831756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/24/2014

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: B-BLACK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2014
• Initial Date FDA Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MOTOR DEVICE