MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC T-PAL SPACER 10MM X 28MM; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number	08.812.008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Patient weight not available for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 or Problem Description
It was reported that during a posterior spinal fusion on (b)(6) 2018, the back portion of the transforaminal posterior atraumatic lumbar (t-pal) spacer broke off while impacting into the disc space.Surgery was completed successfully with no delay.This report is for one (1) 10mm x 28mm t-pal spacer.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 or Problem Description
There was no fragment generated from the broken device.The broken device was easily removed without additional intervention.The patient outcome was great.Concomitant device: impactor-standard bayoneted (part: 03.605.500, lot: unknown, quantity: 1).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: date device received by manufacturer.Device evaluated by mfr: a product investigation was conducted.Visual inspection: the t-pal spacer (part#: 08.812.008, lot#: unknown, mfg#: unknown) was inspected at us cq.Upon visual inspection, it was observed that the t-pal spacer was broken into multiple pieces and the returned fragment was approximately 8mm long and it had the etched ce mark and approximately half of the oval slot.Other broken fragments of the t-pal spacer were not returned.No new issues have been identified.The received condition agrees with the complaint description.Dimensional inspection: dimensional analysis was performed on the t-pal spacer and the width was measured and it falls within the specification per relevant drawing.Document/specification review: the relevant drawing(s) was reviewed; no design or manufacturing defect or deficiency was observed during the investigation.A dhr review could not be performed as the lot number is unknown.Material/hardness review: the material review was not able to be performed as the lot number is unknown.Investigation conclusion: the complaint condition is confirmed.While no definitive root cause could be determined it is possible that the device encountered unintended forces at the time of surgery during the process of advancing the t-pal spacer into the disc space such as force greater than its tolerance during hammering on the applicator to pivot the t-pal spacer into the final position.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: T-PAL SPACER 10MM X 28MM
• Common Device Name: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7693819
• Report Number: 2939274-2018-52913
• Device Sequence Number: 19081490
• Product Code: MAX
• UDI-Device Identifier: 10705034759531
• UDI-Public: (01)10705034759531
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K100089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2018

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
• Operator of Device: Health Professional
• Device Model Number: 08.812.008
• Device Catalogue Number: 08.812.008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 07/20/2018; 07/26/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/06/2018; 08/23/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: . THERAPY DATE: JUNE 25, 2018
• Patient Age: 74 YR