MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 8.0 CM MEDIUM ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number MEDIUM

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.A visual and functional assessment was performed on the device which found that the device failed cutter insertion.It was determined that the issue with the cutter insertion was that the bearings were worn out and loose, creating a situation whereby 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.The device is being returned for further investigation.Once the investigation has been completed, a supplemental medwatch will be submitted.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Event Description

It was reported by (b)(6) that during service and evaluation, it was determined that the nose cone and bearings of the attachment device were damaged.It was further determined that the device had a cosmetic defect and the identification was unreadable.It was further determined that the ball bearings had fallen apart, the extension sleeve was damaged, and the triangle symbol, color ring , balls and cage were missing.It was noted in the service order that the device had an undetermined malfunction.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 the event was unknown.However, it was reported that the event occurred in 2018.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.An assessment was performed which found that the bearings were worn out, creating a situation whereby 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 normal wear over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 8.0 CM MEDIUM ATTACHMENT
• Type of Device: MOTOR, DRILL, ELECTRIC - ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 7628743
• MDR Text Key: 111986167
• Report Number: 1045834-2018-51157
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 845384004899
• UDI-Public: (01)845384004899(11)070821
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MEDIUM
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1