MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 11.0 CM LONG ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number LONG

Device Problems Vibration (1674); Naturally Worn (2988); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer 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 during a spinal decompression surgery, it was observed that the bearings on the attachment device were worn.It was further reported that the device had vibration and chattering noise which were symptoms and clear indication that the bearings were worn.It was not reported if there was no delay to the surgical procedure.It was reported that a spare device was available for use.There was patient involvement reported.There were no 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 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.

Manufacturer Narrative

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the bearings were worn out and loose causing the device to vibrate.Therefore the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 11.0 CM LONG 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: 6465079
• MDR Text Key: 72218789
• Report Number: 1045834-2017-10831
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011444
• 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,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LONG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2013
• 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