MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL TRIAL SPACER 10MM X 28MM 10MM HEIGHT; TEMPLATE

Catalog Number	03.812.310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation, as it was reportedly discarded by the facility.Manufacturing location: (b)(4).Manufacturing date: august 22, 2013.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 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 a transforaminal posterior atraumatic lumbar spacer system (t-pal) trial spacer and a t-pal spacer applicator inner shaft broke during a l4-s1 transforaminal lumbar interbody fusion (tlif) procedure on (b)(6) 2016.The very distal end, rounded piece of the inserter shaft broke off inside the t-pal spacer applicator handle (applicator knob) while being impacted during implantation.The same piece broke on the trial inserter.That is the only spot it broke, and it was only a one piece breakage.The t-pal spacer applicator handle became stripped with the threads still attached, and it appeared dull.The applicator knob then wasn't able to thread on.All fragments were easily retrieved.Nothing was left behind in the patient.There was no reported surgical delay.The procedure was successfully completed with no patient harm.This is report 1 of 2 for com-(b)(4).

• Brand Name: T-PAL TRIAL SPACER 10MM X 28MM 10MM HEIGHT
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6212680
• Report Number: 3003875359-2016-10670
• Device Sequence Number: 717463
• Product Code: HWT
• UDI-Device Identifier: 10705034727851
• UDI-Public: (01)10705034727851(10)8517366
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2016

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 Catalogue Number: 03.812.310
• Device Lot Number: 8517366
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 12/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1