MAUDE Adverse Event Report: SYNTHES BETTLACH SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/13.5MM HEIGHT 12DEG-STER; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Catalog Number 08.802.012S

Device Problem Fracture (1260)

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

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight is not available for reporting.Product code xxx was entered due to system limitations.Product code is ovd.(b)(4).Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: may 20, 2016.Expiration date: apr 30, 2026.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.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 a single level anterior lumbar interbody fusion (alif) procedure at level l5-s1 using the synfix system, the plate developed a crack at the screw-hole.The surgeon had placed the first locking screw with no problem.When placing the second locking screw he had to apply additional force to tighten the screw to the plate and the plate developed a crack at the screw-hole.Although the plate cracked, it did not break in two or generate fragments.It is not known which of the two concomitant screws was the one associated with the plate cracking.The surgeon removed the cracked plate and the two locking screws, and replaced them with another synfix plate and more screws.The procedure was completed successfully with a 10-minute delay.There was no reported harm to the patient.Concomitant device reported: 4.0mm locking screw (part # 04.802.211, unknown lot #, quantity 1); or (part # 04.802.212, unknown lot #, quantity 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The returned synfix implant was examined and the plate¿s cranial right locking hole was found to be cracked.In addition the locking threads for each hole showed deformation and worn anodization consistent with implantation and explantation.No functional test was able to be completed due to post-manufacturing damage.A visual inspection and drawing review were performed as part of this investigation.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No product design issues or discrepancies were observed.The synfix-lr system features a zero-profile anterior lumbar interbody fusion (alif) implant which incorporates the benefits of an anterior fixation plate and a radiolucent interbody spacer; the implant is secured with four locking screws.Screws are inserted with the aid of aiming devices in order to ensure proper trajectory for screw engagement into the fixation plate and vertebrae.Relevant drawings for the implant were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.No definitive root cause was able to be determined however, based on the complaint description it is likely that the application of ¿additional force¿ contributed to the complaint condition.Concomitant product(s): initially, it was reported that there were two concomitant devices 1 x 04.802.211 and 1 x 04.802.212.The concomitant device is 1 x 04.802.211 or 1 x 04.802.212.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/13.5MM HEIGHT 12DEG-STER
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6084311
• MDR Text Key: 59818545
• Report Number: 9612488-2016-10449
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072253
• 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: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.802.012S
• Device Lot Number: 9912400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 04.802.211, 4.0MM TI LOCK SCREW 20MM, QTY 1; 04.802.212, 4.0MM TI LOCK SCREW 25MM, QTY 1
• Patient Age: 45 YR