MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL TRIAL SPACER 10MM X 28MM11MM HEIGHT; TEMPLATE

Catalog Number	03.812.311
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier, age or date of birth, and weight are not available for reporting.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Manufacturing site: (b)(4).Manufacturing date: 20.May 2014.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this 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 or Problem Description
It was reported that during a transforaminal lumbar interbody fusion (tlif) procedure at l5-s1 on (b)(6) 2017, the ball tipped end of the trial spacer broke off into the applicator knob as the surgeon was using it.The broken piece was retrieved and it was confirmed that there was no issue with the applicator knob.A standard x-ray taken during the procedure confirmed that there were no additional fragments.It was reported that the surgeon was able to continue the procedure with the same device without any ill effects to the patient or delay in surgery.The surgery was completed successfully and the patient reported as stable.Concomitant devices reported: t-pal spacer applicator knob (part number unknown, lot number unknown, quantity 1) and t-pal spacer applicator handle (part number unknown, lot number unknown, quantity 1).This report is for one (1) t-pal trial spacer.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product development investigation was performed.The following complaint device(s) was received by customer quality (cq): one t-pal trial spacer 10mm x 28mm11mm height (part number: 03.812.311, lot number: 8909733, mfg date: 20may2014).A visual inspection and device history review were performed as part of this investigation.This complaint is confirmed.The returned t-pal trial spacer (03.812.311) is utilized in the t-pal (transforaminal posterior atraumatic lumbar) system.The selected trial is attached to the applicator handle (03.812.001) and applicator knob (03.812.004) assembly by inserting the trial into the handle shaft while ensuring the arrow on the handle is aligned with the arrow in the trial.Once fully inserted the knob is rotated clockwise until the security ring clicks into position displaying a green band.The knob can then continue to be rotated clockwise until tight; the trial will not pivot in this position.The trial can then be advanced into the intervertebral disc space with light hammering (pdl102).Once in position the applicator knob is rotated counterclockwise until it stops at the security ring, allowing the trial to pivot.The trial can be advanced into the final position with light controlled hammering.The assembly can be removed by attaching a slap hammer (03.809.972) to the proximal end of the knob and the applicator released by depressing the security ring, rotating the knob counterclockwise fully and pushing the release button on the knob.The applicator handle can be utilized, in conjunction with an applicator inner shaft (03.812.003) for implant insertion following the same procedure.The returned trial spacer was examined and the complaint condition was able to be confirmed as the proximal coupling head was found to be broken and was not returned.The remainder of the device was found to be intact with minimal witness marks concentrated on the distal trial consistent with wear and tear; these marks would not inhibit device functionality.Replication is not applicable as the device is already broken.Relevant drawings for the returned instrument were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.The received failure mode is consistent with impaction while the handle (03.812.001) security ring is pressed forward; this would concentrate impaction forces on the proximal coupling ball tip.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.

• Brand Name: T-PAL TRIAL SPACER 10MM X 28MM11MM HEIGHT
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6515392
• Report Number: 3003875359-2017-10194
• Device Sequence Number: 16365134
• Product Code: HWT
• UDI-Device Identifier: 10705034727868
• UDI-Public: (01)10705034727868(10)8909733
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 03/29/2017

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: 03.812.311
• Device Lot Number: 8909733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APPLICATOR HANDLE (PART AND LOT UNKNOWN, QTY 1); APPLICATOR KNOB (PART AND LOT UNKNOWN, QTY 1)