MAUDE Adverse Event Report: SYNTHES BETTLACH SYNFIX-LR TRIAL IMPLANT 8DEG DEPTH 26MM/W 32MM/H 12MM; TEMPLATE

Catalog Number 03.802.016

Device Problem Break (1069)

Patient Problem Sedation (2368)

Event Date 11/20/2015

Event Type  Injury  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received the investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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

It was reported that the tips broke off of two devices during an anterior lumber interbody fusion procedure.The surgeon burred enough of the tips off to complete the surgery.No fragments were left in patient.There was a 20 - 30 minute delay during surgery.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

(b)(6).Manufacturing location: supplier - (b)(4), packaged by (b)(4).Manufacturing date: 20august2008.Part: 03.802.016, lot: 2389111 (non-sterile): 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 device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Event date was provided by reporter on (b)(6) 2016.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.

Manufacturer Narrative

Product investigation summary: the returned instruments were examined (synfix trial ¿ 03.802.016 and trial spacer handle ¿ 389.151) and the complaint condition was able to be confirmed as the distal threaded tip of the trial spacer handle was found to be broken.The trial spacer¿s threaded hole shows signs of the tip being removed.A definitive root cause was unable to be determined; however, the failures are consistent with rough handling/cross threading.The trial spacer handle is utilized within the synfix system for implant sizing.A trial spacer handle is threaded into a synfix trial and inserted into the disc space with controlled and light hammering.The returned instruments were examined and the complaint condition was able to be confirmed as the distal threaded tip of the trial spacer handle was found to be broken.The trial spacer¿s threaded hole shows signs of the tip being removed.The relevant drawings for the returned device were reviewed.The instrument was manufactured to a previous revision, prior to the implementation of design improvements.The spindle material has since been changed from 440a stainless steel to custom 465 for added strength.In addition, a drawing for the trials was reviewed.The drawing calls out the appropriate thread and thread depth to fully seat the spindle assembly.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Device 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 8DEG DEPTH 26MM/W 32MM/H 12MM
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CO CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CO CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5288539
• MDR Text Key: 33241197
• Report Number: 8030965-2015-12248
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.802.016
• Device Lot Number: 2389111
• Other Device ID Number: (01)10705034722115(10)2389111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2008
• 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 Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 85