MAUDE Adverse Event Report: SYNTHES USA TRIAL MEDIUM 6 DEG 10MM-NON STERILE; TEMPLATE

Catalog Number SFW651R

Device Problem Break (1069)

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

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient id/initials, age and weight are unknown.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.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.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.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

Device report from synthes (b)(4) reported the following event: it was reported that during a procedure to mobilize the disc space using the prodisc-l trial spacer, upon levering the handle of the trial spacer, the shaft of the trial spacer broke and separated from the head of the trial spacer.Both the head and the shaft of the trial spacer were removed from the patient without incident.The patient is stable and no harm was reported.Procedure was completed with a similar trial spacer.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional information: a product development evaluation was performed for the subject device (part number sfw651r, lot number unknown, prodisc-l 10mm medium 6 degree trial spacer).The subject device was received with the complaint stating that the shaft broke and separated from the head of the trial spacer.Upon visual evaluation of the returned item, it was observed that the shaft sheared off from the welding that connected the shaft and the head of the instrument.Both the shaft and the head of the trial spacer were returned.The 10mm medium 6 degree trial spacer is part of the prodisc-l total disc replacement system.The prodisc-l system is ¿intended to replace a diseased and/or degenerated intervertebral disc of the lumbosacral region¿ between l3 and s1.The system contains 12 trials that correspond to the 12 possible prodisc l implant sizes.These trials are placed into the disc space intraoperatively to determine the appropriate implant foot-print, lordotic angle, and disc height per the prodisc l technique guide.The product drawings were reviewed during the investigation and the returned trial met dimensional specifications.The laser etch on the returned shaft was not consistent with the laser etch detailed in one of the drawing revisions.The instrument was etched with the company logo ¿spine solutions inc.¿ indicating that the item was likely manufactured prior to synthes¿ acquisition of spine solutions inc.In april 2003.Since the current drawings were active as of 2007, the available archived versions dating back to 2004 were also reviewed and the etching on this version also did not match the returned item.Aside from the change in the etching, the dimensions of the trial remained the same between the versions.As a lot number could not be found on the returned device, a device history record review could not be performed and the exact date of manufacture cannot be confirmed.There is insufficient information available to determine the true root cause of the failure however it is likely that repeated impactions, on- and off-angle, over time could result in fatigue of the material making it more susceptible to a fracture, especially at the areas of least material.With a multiuse instrument of this age, it is unlikely that the failure is related to the design of the product.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRIAL MEDIUM 6 DEG 10MM-NON STERILE
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5336008
• MDR Text Key: 34761240
• Report Number: 2520274-2015-18134
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SFW651R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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