MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 8CM HEAVY DUTY MEDIUM ATTACH; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number MEDIUM-HD-G1

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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 pre-surgery, it was discovered that the bearings fell out of the attachment device.There were no delays to the planned surgical procedure as an identical spare device was available for use.There was no patient involvement reported.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.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the bearing stack screw failed which allowed the screw to move proximally and disengage.It was determined that this was due to loctite degradation/failure on the screw.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 8CM HEAVY DUTY MEDIUM ATTACH
• Type of Device: MOTOR, DRILL, ELECTRIC - 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: 5306097
• MDR Text Key: 34400972
• Report Number: 1045834-2015-12798
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK133604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MEDIUM-HD-G1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2014
• 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