MAUDE Adverse Event Report: SYNTHES USA; EXTRACTOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Response, Increased (2272)

Event Date 05/13/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the surgeon wanted to change the direction of the plate (rotation to locking) during a valgistation osteotomy of the right knee but it was impossible to unlock the screw.The screw extractor broke during the attempted loosening.The screw had to be cut to remove the material.Osteotomy began with the saw and finished with the power tool.The plate had to be changed as well due to not being able to unlock the screw.No piece was left in the patient.The patient was given an extra dose of antibiotic.There was a surgical delay of more than thirty minutes.This report is for an unknown screw extractor.This is report 5 of 5 for (b)(4).

Manufacturer Narrative

This report is for an unknown screw extractor/unknown lot.Implant/explant date: device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3905476
• MDR Text Key: 18066828
• Report Number: 2520274-2014-12251
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2014
• 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
• Patient Outcome(s): Required Intervention