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

Catalog Number 351.16J

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Device is an instrument and is not implanted or explanted.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the service history record review could not be completed.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 mechanism for a flexible shaft connector for use with (b)(6), which consisted of a spring, pin, bolt, and screw, came apart and could not be put back together during a retrograde femoral nail procedure on (b)(6) 2015.Another part from another set was available for use.No patient harm or surgical delay reported.This report is 1 of 1 for com-(b)(4).

• Brand Name: FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5024357
• MDR Text Key: 23859670
• Report Number: 2520274-2015-15411
• 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: Other
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 351.16J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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