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

Catalog Number 351.16J

Device Problems Loose or Intermittent Connection (1371); Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Service history record review: no service history review can be performed as part 351.16j with lot 8798091 is a lot/batch controlled item.The release to warehouse date of this item is april 9, 2014.The service history review is unconfirmed.Device history record review: manufacturing location: (b)(4).Manufacturing date: april 4, 2014.A non-conformance report (ncr) was generated during production documenting a rework, which has no influence on reported issue.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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

It was reported that the pins of a flexible shaft connector were loose and falling out.Although the event occurred during a surgical procedure, the patient was out of reach and therefore not directly affected.The pins that fell out were retrieved; another device was available for use to complete the surgery without delay or patient harm.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Service & repair evaluation: the customer reported the pins kept falling out.The repair technician reported the chuck sleeve screw was missing.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: chuck sleeve screw.The item was repaired per the inspection sheet and passed the synthes final inspection on june 14, 2016.The device will be returned to the customer upon completion of the service and repair process.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.

• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5725769
• MDR Text Key: 47413830
• Report Number: 9612488-2016-10270
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2016

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: 351.16J
• Device Lot Number: 8798091
• Other Device ID Number: (01)10886982193742(10)8798091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 06/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2014
• 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