MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 5 CM HEAVY DUTY SHORT ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number SHORT-HD-G1

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(4).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 prior to surgery, it was observed that the bearings fell out fo the attachment device.It was not reported whether there were any delays in a planned surgical procedure or whether 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 the reported condition was confirmed.It was determined that the device had missing ball bearings, spacer and bearings spacer.The assignable root cause was determined to be due to device wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• Brand Name: 5 CM HEAVY DUTY SHORT ATTACHMENT
• 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: 6058016
• MDR Text Key: 58771592
• Report Number: 1045834-2016-13069
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133604
• 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: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SHORT-HD-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• 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