MAUDE Adverse Event Report: SYNTHES BETTLACH FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK; REAMER

Catalog Number 351.16J

Device Problems Failure To Adhere Or Bond (1031); Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted / explanted.No service history review can be performed as part number 351.16j with lot number 8053605 is a lot/batch controlled item.The release to warehouse date of this item is sep 12, 2012.Device history records review was completed for part # 351.16j with lot # 8053605.Manufacturing location: (b)(4), manufacturing date: sep 05, 2012.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes service and repair department documented that a flexible shaft connector for use with jacobs chuck came apart and will not stay together.Additionally, one set screw is in place and the other is missing.The sales consultant relayed that the set is used three to five times a week to put nails in.The issue was found during cleaning.There was no patient involvement.This report is for one (1) flexible shaft connector for use with jacobs chuck.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A service and repair evaluation was performed.The customer reported the item came apart and would not stay together.The repair technician reported the chuck sleeve screw was missing, one of the chuck pins was missing and the other pin was broken.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: chuck sleeve screw, chuck pin (2).The item was repaired per the inspection sheet, passed synthes final inspection on 14-nov-2016 and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6086215
• MDR Text Key: 59466899
• Report Number: 9612488-2016-10451
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 351.16J
• Device Lot Number: 8053605
• Other Device ID Number: (01)10886982193742(10)8053605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2012
• 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