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

Catalog Number SHORT

Device Problem Component Falling (1105)

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

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 1 of 2 for the same event: it was reported from australia that during an unspecified surgical procedure, it was observed that one attachment device had a bearing ring fell out completely while the other attachment device had fragments fell out.It was reported that the event occurred while pulling the drill bit device out.It was further reported that the event occurred after use on the patient and therefore no fragments fell inside of the patient.According to the reporter, there was no visual damage observed prior to the use of the devices.There were no delays in the surgical procedure.It was not reported if spare devices were available for use.There was patient involvement reported.There was no potential adverse event reported.There was no reports of 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

Udi: (b)(4).Incorrect serial number.The serial number was incorrectly documented.The serial number has been updated from (b)(4) to (b)(4) accordingly.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

The date returned to manufacturer was documented as sep 21, 2016 on the previous report.It has been updated as oct 4, 2016.The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the distal bearing had failed.It was determined that the cause of the bearing ring falling out was due to a failed bearing.Therefore, the reported condition was confirmed.The assignable root cause of the failed bearing was determined to be due to normal wear over time.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• 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: 5949175
• MDR Text Key: 55048694
• Report Number: 1045834-2016-12714
• 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: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SHORT
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2014
• 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
• Treatment: ATTACHMENT DEVICE; DRILL BIT DEVICE