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

Catalog Number LONG

Device Problem Naturally Worn (2988)

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

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that during an unspecified surgical procedure, it was observed that the long attachment device bearings were worn.It was reported that there was no delay in the procedure due to the event as an unspecified spare device was available for use.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no 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 was returned for evaluation.Reliability engineering evaluated the device and determined that the device had worn bearings.Therefore, the reported condition was confirmed.An assessment was performed on the device which found that the device failed the cutter insertion assessment.It was also observed that the device had a bend on the tip of the nose tube and excessive scratches on the nose cone.During repair it was observed that the bearings were worn out and loose creating a situation where the cutter is not able to be inserted.It was determined that this is because the bearings are no longer in axial alignment not allowing the cutter to pass through.The assignable root cause of this condition was determined to be component damage from normal use over time, the failure was caused by worn out bearings.It was further determined that the condition the nose tube and the nose cone is consistent with mishandling of the device and/or from excessive force being placed on the device during use.The assignable root cause was determined to be component damage due to user error.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: 6634428
• MDR Text Key: 77370339
• Report Number: 1045834-2017-11286
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 06/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2011
• 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