MAUDE Adverse Event Report: SYNTHES (USA) SELF-RETAINING SCREWDRIVER; TRAY,SURGICAL INSTRUMENT

Catalog Number 387.282

Device Problem Sticking (1597)

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

Event Date 03/18/2014

Event Type  malfunction  

Event Description

It was reported that when the temporary fixation pins are inserted through a plate into bone, they stick to the driver, and it is very difficult to remove the driver causing pulling on the vertebral body.The procedure was delayed by fifteen to thirty minutes.The procedure was completed by using the same or like product.The patient's status/outcome following the procedure was reportedly stable.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

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 is an instrument and not implanted/explanted.(b)(6).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: SELF-RETAINING SCREWDRIVER
• Type of Device: TRAY,SURGICAL INSTRUMENT
• 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: 3708688
• MDR Text Key: 4330989
• Report Number: 2520274-2014-10468
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• 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: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 387.282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2014
• 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