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

Catalog Number LONG

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

(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.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, bearings and extension sleeve of the attachment device were damaged.It was determined that the device identification was unreadable and the caption was almost unreadable.It was further determined that the balls and cage were missing.It was observed that the ball bearing had fallen apart.It was further determined that the device failed pretest for lock operation and cutter insertion.It was noted in the service order that the device was not working.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.The device was tested and it was determined that a cutter device could not be inserted into the device.It was further determined that the cutter could not be inserted because the bearings were worn out, not allowing the cutter to pass through.The assignable root cause was determined to be due normal wear out from use.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 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: 7656143
• MDR Text Key: 113009279
• Report Number: 1045834-2018-51197
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 845384003571
• UDI-Public: (01)845384003571(11)160517
• 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: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• 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: 05/11/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2016
• 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