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

Catalog Number LONG

Device Problems Component Missing (2306); Incorrect Or Inadequate Test Results (2456); Low Test Results (2458); Mechanics Altered (2984); Physical Property Issue (3008); Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).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.

Event Description

It was reported by (b)(6) that during service and evaluation, it was discovered that the bearings were damaged on the attachment device.It was further determined that the ball bearings had fallen apart and the cage was missing.It was further determined that the pins had moved and the extension sleeve was damaged.It was further determined during the pre-repair diagnostics assessment that the device failed for cutter insertion(ball bearing) and for visual assessment(pins).It was noted on the service order that the bearing was damaged.This event did not occur during surgery.There was no patient involvement.There were no reports of 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.

Manufacturer Narrative

Device availability: the device availability date was incorrectly documented.The date returned to manufacturer was corrected from oct 11, 2016 to nov 16, 2016.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.It was determined that the bearings were worn out and loose, which created a situation where the cutter device was not able to be inserted.That was because the bearings were no longer in axial alignment not allowing the cutter to pass through.It was determined that the failure was caused by worn out bearings.The assignable root cause was determined to be due to worn out bearings from normal use and servicing over time.If additional information should become available, a supplemental medwatch report 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: 6064712
• MDR Text Key: 59014044
• Report Number: 1045834-2016-13090
• 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,foreig
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LONG
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2015
• 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