MAUDE Adverse Event Report: SYNTHES BETTLACH TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 03.802.431

Device Problem Device Difficult to Maintain (3134)

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

Event Date 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information not provided by reporter.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), 03.802.431, lot# 9125361, manufacturing date: 29.Sep.2014, no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that an anterior lumbar interbody fusion (alif) surgery from l5-s1 was performed on (b)(6) 2016.Three issues were noted during this surgery.While attempting to tighten the retractor blade onto the synframe guide rod (387.358), the screw on the guide rod kept spinning then stripped.Surgery proceeded using the remaining 5 rods to distract the tissue.A 30 seconds delay was noted.The tapered u-joint driver(03.802.431) would not retain the screw.Surgeon used bone wax to hold the screw and driver together however, was unsuccessful.Another driver was used and screws were successfully implanted.No issues with the screws.A 15 seconds delay was noted.While disassembling the synframe holding ring (387.336) at the back table, the screw on one of the half ring (387.337) stripped.No issues with the device during assembly and while in used.No surgical delay noted.Procedure was successfully completed with a 45 seconds surgical delay total.No patient harm.No fragments generated.Devices will be returned for evaluation.This report (b)(4).

Manufacturer Narrative

A product investigation was completed: the returned instruments were examined and the complaint condition was able to be confirmed as the damage on the devices was consistent with the complainant¿s report.The head of the u-joint driver was deformed along the edges.Per the techique guide, the tapered u-joint driver is part of the synfix-lr system which is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (ddd).The instrument is specifically designed to insert 15- 30mm synfix locking screws.The u-joint mechanism of 03.802.431 is designed to allow the transmission of torque to the tip at angles not achievable by a straight driver.The associated drawings for the tapered u-joint driver were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history record review was performed for the tapered u-joint driver¿s and in each instance no material review reports, non-conformance reports or complaint-related issues were identified with the lots numbers which may have contributed to the complaint condition.The returned instruments were examined and the complaint condition was able to be confirmed in each instance as the distal driver tips were found to be worn.No definitive root cause was able to be determined however the failure mode is consistent with the application of torque when the tip is not fully seated into the screw drive recess.No definitive root cause could be identified however all the instruments display signs of normal wear and tear and use of excessive force.It is likely that the age of the devices and the use of excessive force contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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.

Event Description

This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5399864
• MDR Text Key: 37183800
• Report Number: 9612488-2016-10064
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.802.431
• Device Lot Number: 9125361
• Other Device ID Number: (01)10705034722436(10)9125361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2014
• 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