MAUDE Adverse Event Report: SYNTHES USA 4.3MM THREADED LCP(TM) DRILL GUIDE

Catalog Number 323.042

Device Problems Break (1069); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.Device was 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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported the device was sent in for unknown or routine servicing.The service technician identified the device was worn-out and tip was broken.There were no injuries, patient user involvement or surgery delay or need for additional medical intervention reported.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

A review of the device history records (dhr) was attempted, but as the manufacturing details are not available the dhr could not be performed.A product investigation was completed: the review of the service order form from the affiliate in (b)(4) indicates the device was sent in for service for the following: further to this the service technician identified the following: general, worn out, tip breakage.Investigation confirmed following: general, worn out and tip breakage.The manufacturing details of the product could not be retrieved.The service history was not available and dhr could not be performed.The service technician noted the action taken as exchange, replacement.Functional testing of the device has been performed in accordance with the service manual.The service technician identified the probable root cause as improper handling.The device was serviced and returned to the customer.Device was 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: 4.3MM THREADED LCP(TM) DRILL GUIDE
• Type of Device: GUIDE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5705952
• MDR Text Key: 46782042
• Report Number: 2520274-2016-13055
• Device Sequence Number: 1
• Product Code: FZX
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 323.042
• Device Lot Number: 7868794
• Other Device ID Number: (01)07611819246607(10)7868794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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