MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 12.4CM HEAVY DUTY LONG ATTCH; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number LONG-HD

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that during decontamination in the sterile processing department, it was observed that the clip and washer on the long attachment device fell out.It was not reported whether there were any delays in a surgical procedure of if a 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 snap ring (c-clip) and washer were missing and preventing pre-test from being completed.It was also noted that the bearings were worn out.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to worn out bearings and normal use and servicing over time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 12.4CM HEAVY DUTY LONG ATTCH
• 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: 5485947
• MDR Text Key: 40132712
• Report Number: 1045834-2016-10631
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011444
• 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: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LONG-HD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2009
• 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