MAUDE Adverse Event Report: SYNTHES USA TAP F/2.0MM RESORBABLE CORTEX; TAP BONE

Catalog Number 311.064.01S

Device Problem Metal Shedding Debris (1804)

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

Event Date 03/17/2014

Event Type  malfunction  

Event Description

It was reported that a surgeon was performing a craniectomy for a brain tumor removal.After the removal they were repairing by placing absorbable mesh plate at the site and using a bone tap to prepare the holes for the screws.On the placement of the last screw, the bone tap sheared apart at the threads.The distal tip of the tap remained within the patient.The surgeon used a burr to expose the fragment and used hemostats to remove it.The event resulted in a 15 minute delay.The surgeon was able to complete the procedure successfully without any reported patient harm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

This device used for treatment, not diagnosis.(b)(6).Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided.Manufacturing records could not be reviewed without a lot number.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TAP F/2.0MM RESORBABLE CORTEX
• Type of Device: TAP BONE
• 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: 3727154
• MDR Text Key: 17615182
• Report Number: 2520274-2014-10576
• Device Sequence Number: 1
• Product Code: HWX
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/18/2014

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
• Device Catalogue Number: 311.064.01S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 69 YR
• Patient Weight: 45