MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 5.0CM SHORT ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number SHORT

Device Problem Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 01/27/2016

Event Type  malfunction  

Manufacturer Narrative

Initial reporter's phone number extension: (b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.A pre-repair diagnostic assessment was performed on the device which found that the interface of the attachment to motor was according to specification.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the color bands were missing there was vibration.During repair and disassembling of the device it was discovered that the bearings were worn and corroded thus creating the vibration.The assignable root cause was determined to be component wear from normal use over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that during pre-surgery testing it was observed that the sort attachment device would not attach to the handpiece device.The reporter stated that the knurled knob did not "click" to secure the attachment device.During in-house engineering evaluation it was found that the color bands were missing and there was vibration on the device.It was reported that there were no delays to a scheduled surgical procedure as an unspecified spare device was available for use.There was no patient involvement.There were no patient or user injuries reported.It was reported there was no 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: 5.0CM 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: 5507306
• MDR Text Key: 40831266
• Report Number: 1045834-2016-10813
• 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
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SHORT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Date Manufacturer Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2012
• 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