MAUDE Adverse Event Report: SYNTHES USA TEMPLATE FOR OCCIPITAL PLATE/ROD

Catalog Number 388.869

Device Problem Break (1069)

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

Event Date 03/04/2014

Event Type  malfunction  

Event Description

It was reported that the surgeon was bending the trial rod to fit the patient¿s anatomy and it snapped.Then, when he went to cut the excess rod the cutting surface of the pliers, it chipped off.The case was not prolonged as another rod cutter was used.There was no harm to the patient noted.No fragments went near the patient as the rod cutting takes place away from the patient.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

This device was used for treatment, not diagnosis.Device is an instrument and is not implanted / explanted.Investigation could not be completed, no conclusion could be drawn as no device was returned.Review of manufacturing records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TEMPLATE FOR OCCIPITAL PLATE/ROD
• Type of Device: TEMPLATE
• 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: 3771220
• MDR Text Key: 4377141
• Report Number: 2520274-2014-11044
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2014
• 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