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

Catalog Number B-TURQ-L

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 01/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device was getting hot.A visual and functional assessment was performed on the device which found that the device was running at 128 degrees which was above the operational temperature specification (118 degrees).It was observed that the device showed signs of damage that was indicative of damage caused by worn out bearings which was consistent with normal wear over time.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal use and servicing over time.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the motor device did not stop when the foot was released from the pedal.As a result, it was reported that the perforator device plunged through the dura (located under the skull and around the brain that keeps the cerebrospinal fluid from leaking).During in-house engineering evaluation, it was observed that the attachment device was getting hot.It was determined that the attachment device was running at 128 degrees which was above the operational temperature specification (118 degrees).It was reported that the devices were used together during use on a patient.It was not reported if there were any delays in the surgical procedure or if spare devices were available.There was patient involvement reported.It was unknown if there were any medical intervention or prolonged hospitalization.The patient's outcome post-surgery was unknown.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 ATTACH, BM
• 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: 6643444
• MDR Text Key: 77641919
• Report Number: 1045834-2017-11319
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2017

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-TURQ-L
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2007
• 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
• Treatment: ATTACHMENT DEVICE; COMPACT SPEED REDUCER DEVICE; MOTOR DEVICE