MAUDE Adverse Event Report: SYNTHES USA; EXTRACTOR

Device Problem Difficult to Remove (1528)

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

Event Type  malfunction  

Event Description

This report is being filed after subsequent review of the following journal article, "clinical experience with the screw extraction set for broken screw" (2011).Mitsukawa, n.(2011).Clinical experience with the screw extraction set for broken screw.The journal of craniofacial surgery, 22 (1), 226-229.There was 1 unknown patient with an unknown synthes plating system and 6 unknown patients with a competitor plating system that could not be explanted according to the technique guide for an unknown synthes extraction set.This is report 2 of 2 for (b)(4).This report is for an unknown extraction system.

Manufacturer Narrative

Device used for treatment, not diagnosis.Mitsukawa, n.(2011).Clinical experience with the screw extraction set for broken screw.The journal of craniofacial surgery, 22 (1), 226-229.This report is for an unknown distractor set/unknown quantity/unknown lot.Device is an instrument that 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.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: 4337148
• MDR Text Key: 5223430
• Report Number: 2520274-2014-15282
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/20/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 12/17/2014
• 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