MAUDE Adverse Event Report: SYNTHES BETTLACH SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/13.5MM HEIGHT 12DEG-STER; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Catalog Number 08.802.004S

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight is not available for reporting.Due to system limitations, device product code ovd could not be entered.Lot number is not available for reporting.Other number¿(b)(4) expiration date unknown (10) lot number unknown.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, no implant/explant dates are applicable.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 fusion at levels l5 to s1 on (b)(6) 2016, as the surgeon was implanting the synfix device, the lateral peek flange which connects to titanium plate broke off.The surgeon was able to retrieve the broken fragment and confirmed that no fragments remained in the patient with an x-ray.The surgeon was able to implant another readily available device and complete the procedure without further complications.There was a delay of approximately five minutes due to the reported event.There was no patient harm reported.The patient's postoperative status was reportedly stable.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A device history record review was performed for the complaint 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 complaint device.Manufacturing location: synthes (b)(4).Manufacturing date: apr 21, 2015.Expiration date: apr 1, 2025.The complaint device is currently in the investigation process.The results of the investigation are pending completion.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A product investigation was completed: the complaint condition is confirmed.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended and the risk assessment, where applicable, was found to adequately address the complaint condition.Per the technique guide, the returned implant is part of the depuy synthes synfix-lr system.The implant is a stand-along alif device that incorporates the benefits of an anterior plate and a radiolucent interbody spacer.The design creates a zero-profile construct and includes four locking screws that provide anterior fixation and stability.Upon visual examination of the implant is can be seen that one side of the of the insertplate portion of the implant that holds the tan spacer intact has broken off into a fragment that was not returned.The fracture is located along the 13.5mm etching.A device history record review was done for the part and no non-conformance reports 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.The relevant drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.A root cause could be determined as the specific circumstances surrounding the event are unknown.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

Concomitant devices reported: titanium plate (part unknown, lot unknown, quantity unknown).

• Brand Name: SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/13.5MM HEIGHT 12DEG-STER
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA 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: 5805521
• MDR Text Key: 49943948
• Report Number: 2520274-2016-13526
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.802.004S
• Device Lot Number: 9398878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/05/2016; 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR