MAUDE Adverse Event Report: SYNTHES MONUMENT CONICAL EXTRACTION SCREW FOR 5.5MM LOCKING SCREWS

Catalog Number 03.600.001

Device Problem Material Deformation (2976)

Patient Problem Fall (1848)

Event Date 01/17/2014

Event Type  malfunction  

Event Description

It was reported that the patient was implanted with click¿x on a unknown date.Later, it was discovered that the patient fell and was suspected to have pseudarthrosis at l5-s1.A revision surgery was performed on (b)(60 2014 and click¿x was explanted and expedium was implanted into the patient at levels t8 to the pelvis.During the removal of the transconnector the tip of the driver sheared off.The rescue driver became stuck in the handle at the end of the case.The implant and instrument was easily removed without additional intervention.Procedure was successfully completed without any delay.This is report 3 of 7 for complaint (b)(4).

Manufacturer Narrative

(b)(6).A device history review was conducted.The report indicates that precision edge surgical products manufactured the conical extraction screw for 5.5mm locking screws, p/n 03.600.001, and lot number pe00064 for po 1114245.The supplier¿s certificate of compliance (dated 3/26/09) indicates the parts were manufactured to p/n 03.600.001, revision ¿a¿ and met the required specifications.The lot was inspected and conformed to the synthes, incoming final inspection sheet number 036if00001, revision ¿c¿ (dated 1/15/10).There were no mrr¿s, ncr¿s, or complaint related issues with this complaint.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.Placeholder.

Manufacturer Narrative

A product development event evaluation was performed.The most recent versions of the drawings for these parts were reviewed as part of this evaluation.No changes in design have been implemented since these parts were manufactured.

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Upon further review of the complaint file, it was discovered that complained part #03.600.001 was received stuck in part #03.620.100.Both parts were received on february 3, 2014.This error was noted on may 14, 2014.Device was used for treatment, not diagnosis.(b)(4).

• Brand Name: CONICAL EXTRACTION SCREW FOR 5.5MM LOCKING SCREWS
• Manufacturer (Section D): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3626528
• MDR Text Key: 4206345
• Report Number: 1719045-2014-00104
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2014

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: 03.600.001
• Device Lot Number: PE00064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2014
• Initial Date FDA Received: 02/13/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/15/2014; 09/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR