MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS RECIPROCATING MICRO SAW; DRILLS, BURRS, TREPHINES & ACCESSORIES - MICRO SAW

Catalog Number R-SAW_LL

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to worn out motor components 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 that during pre-surgery, it was discovered that the micro saw device did not reciprocate when attached to the driver device.During an in-house engineering evaluation, it was observed that the driveshaft was broken off causing the saw to not reciprocate.It was reported that the there were no delays and a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: RECIPROCATING MICRO SAW
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES - MICRO SAW
• 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: 5952449
• MDR Text Key: 55153998
• Report Number: 1045834-2016-12729
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: R-SAW_LL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2013
• 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