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

Catalog Number LONG

Device Problems Break (1069); Component Falling (1105); Material Disintegration (1177); Component Missing (2306); Device Operates Differently Than Expected (2913)

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

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 the attachment device had an undetermined malfunction.During the pre-repair diagnostics assessment, it was determined that the device had damaged component to the bearings.It was further determined that the ball bearing had fallen apart, the balls and cage were missing, the two clamping pins had wandered out, and the extension sleeve was damaged.It was further determined that the device failed for visual assessment (fail pins) and for cutter insertion (fail ball bearing).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

Additional narrative: correction: 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

Device availability: the device availability date was incorrectly documented.The date returned to manufacturer was corrected from nov 17, 2016 to nov 16, 2016.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 device failed cutter insertion as the cutter could not be fully inserted into the device and that the device failed the cone verification.It was further observed that the device was corroded and the nose tube locking screw could not be disassembled from the nose tube.It was determined that the failed cutter insertion was caused by the bearings being worn out and loose, creating a situation where the cutter was not able to be inserted.The bearings were no longer in axial alignment and did not allow the cutter to pass through.It was determined that the failed cone verification was due to a worn nose cone.It was further determined that the nose tube could not be disassembled due to corrosion.It was determined that the worn out bearings, corrosion, and worn nose cone were due to normal wear over time.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 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: 6056833
• MDR Text Key: 58743256
• Report Number: 1045834-2016-13038
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2016

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: 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: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2014
• 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