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

Catalog Number 03.802.431

Device Problems Dull, Blunt (2407); Device Operates Differently Than Expected (2913)

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

Event Date 01/04/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently in the evaluation process.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 during an anterior lumbar interbody fusion at the levels l3-l5 on (b)(6) 2016, two synfix mini tapered u-joint driver tips slipped a bit and appeared stripped or worn.The patient initially present with l3-l5 levels severely collapsed and a flat nature to her back at those levels.During the surgery, access was performed at both levels using a standard retroperitoneal approach.The disc was excised at both levels using anterior instruments.Height was restored using distractors and trials until the correct anatomic heights were reached and final trials for synfix-lr were placed midline.A synfix implant was attached to the open guide and placed at the l4-5 level.Holes were allowedthrough the guide and then fine tip locking screws were placed.On the left side screw and upper right screw the straight synfix driver on ratchet handle was used.Upon final engagement of the screw to the plate two synfix mini tapered u-joint driver tips slipped a bit and appeared stripped or worn.The drivers were placed back in guide and final tightening achieved.The same procedure performed for the l3-4 level but with a synfix-lr.Upon placing the four fine-tip locking screws in the implant there were several times the t-15 shaft appeared to spin or strip out while tightening the screws thru the mini-open guide.Final tightening was achieved using a backup straight driver along with backup angled mini open driver.There was a 3 to 4 minute surgical delay.The surgery was completed successfully and there was no patient harm.This complaint addresses the two synfix mini tapered u-joint drivers.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device previously reported as received by manufacturer, added date received.A product investigation was completed: per the technique guide, the tapered u-joint driver for synfix (03.802.431) and screwdriver shaft t15 (03.802.030) are components of the synfix-lr system which is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (ddd).Both instruments are 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 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.The associated drawings for the tapered u-joint driver (03.802.431) and the locking t-15 shaft 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 devices 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.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.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.

• Brand Name: TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN
• Type of Device: INTERVERTEBAL FUSION DEVICE W/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: 5374417
• MDR Text Key: 36255680
• Report Number: 9612488-2016-10031
• 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
• Report Date: 01/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2016
• 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: 2660808
• Other Device ID Number: (01)10705034722436(10)2660808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2010
• 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: 56 YR
• Patient Weight: 86