MAUDE Adverse Event Report: SYNTHES BETTLACH SYNFIX-LR TRIAL IMPLANT 12DEG DEPTH 26MM/W 32MM/H 12MM; TEMPLATE

Catalog Number 03.802.017

Device Problem Sticking (1597)

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

Event Date 06/23/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the synfix trial device for spacer was used for a anterior lumbar interbody fusion (alif).The thread inside trial has stripped out.The surgeon put the device in and was not able to remove the device right away from between the two vertebral spaces.The device was eventually retrieved by prying it out.Another set of sterile trial device was used to complete the case with no adverse event to the patient.The procedure was delayed for about twenty minutes.This report is 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.A review of the device history records was performed and no complaint related issues were found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A manufacturing evaluation was performed.The investigation of the complaint articles has shown that: our investigation has shown that the inner thread of the returned trial implant is indeed badly damaged (not able to be used anymore).It is also clearly visible that the trial implant as such is heavily worn.Based on these findings we can clearly indicate that excessive use over the years (manufactured in july 2008) finally resulted in these damages.Further investigation showed conformity of the article in question to the company specification and no apparent fault of material or manufacturing was detected.Therefore we conclude that the cause of failure is not due to any manufacturing non-conformances and we determine the complained malfunction as normal wear and tear after frequent use.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: SYNFIX-LR TRIAL IMPLANT 12DEG DEPTH 26MM/W 32MM/H 12MM
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3942792
• MDR Text Key: 4534219
• Report Number: 9612488-2014-10292
• Device Sequence Number: 1
• Product Code: HWT
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2014

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: 03.802.017
• Device Lot Number: 2322354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2014
• Initial Date FDA Received: 07/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2008
• 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: 47 YR