MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 112.6CM TAPERED ATTACH, BM; BUR, SURGICAL, GENERAL AND PLASTIC SU

Model Number B-TURQ-L_LL

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2014

Event Type  malfunction  

Event Description

During engineering eval, it was observed that the attachment device failed the temperature acceptance test, exceeded acceptable temperature limits.This event was not related to surgery.There was no pt involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available info has been disclosed.If add'l info should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Device eval: the actual device was returned for eval.The device was evaluated and the reported condition was confirmed.If add'l info should become available, a supplemental medwatch report will be sent accordingly.(b)(4).

• Brand Name: 112.6CM TAPERED ATTACH, BM
• Type of Device: BUR, SURGICAL, GENERAL AND PLASTIC SU
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside dr.; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside dr.; palm beach gardens, FL 33410 ; 5614943766
• MDR Report Key: 3888092
• MDR Text Key: 4539271
• Report Number: 1045834-2014-00004
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2014

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 Model Number: B-TURQ-L_LL
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1