MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 11.25CM ATTACHMENT, BLACK MAX; INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC - ATTACHMENT

Catalog Number B-BLUE-S

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

Udi: gtin is unavailable as the product made prior to compliance date; (b)(4).Initial reporter's phone number: (b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was duplicated and confirmed.It was determined that the bearings were worn out and corroded causing the device to run over the temperature specification.The assignable root cause was determined to be due to component damage from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from (b)(6) that the bearings in the attachment device were failing.During service and evaluation, it was observed that the attachment device temperature ran above specification (119 degrees should be less than 118 degrees).This event did not occur during surgery.There was no 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: 11.25CM ATTACHMENT, BLACK MAX
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC - 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: 6328947
• MDR Text Key: 67394085
• Report Number: 1045834-2017-10402
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/28/2016

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-BLUE-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2013
• 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