MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 12.6CM TAPERED ATTACHMENT, BLACK MAX; BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT

Catalog Number B-TURQ-L

Device Problem Device Inoperable (1663)

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

Event Date 07/10/2015

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.A functional assessment was performed and the device meets all manufacturer specifications.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.

Event Description

It was reported that during an unspecified spine surgery, it was observed that the attachment device did not lock in the drill bit device.There were no delays to the surgical procedure as an identical spare device was available for use.The surgical procedure was completed successfully.There was 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: 12.6CM TAPERED ATTACHMENT, BLACK MAX
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY - 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: 4997698
• MDR Text Key: 24062896
• Report Number: 1045834-2015-11737
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK974025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B-TURQ-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2011
• 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