MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL TRIAL SPACER 10MM X 28MM8MM HEIGHT; TEMPLATE

Catalog Number 03.812.308

Device Problem Separation Failure (2547)

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

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Without a lot number the device history records review could not be completed.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.

Event Description

It was reported that on (b)(6) 2016 the patient underwent a posterior lumbar interbody fusion surgery (l4-s1).During the procedure the scrub technician discovered that the transforaminal posterior atraumatic lumbar (t-pal) system inserter (i.E.Handle, knob and trial spacer) could not be separated.Another set of instruments was available for the surgeon to complete the procedure.There was no harm reported to the patient.There was no surgical delay reported.This report is for one (1) t-pal trial spacer.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

The returned instruments were received assembled together; however the instruments were easily able to be taken apart as intended and reassembled again with no issues.This was done several times and in each instance the complaint description could not be simulated.As the complaint was unable to be replicated and no defects or deficiencies were identified with the returned instrument, no further investigation is necessary.The complaint is unconfirmed.The root cause of the complaint condition is unknown as the circumstances during the time of the event are unknown.The t-pal spacer applicator inner shaft (03.812.003) is utilized in the t-pal (transforaminal posterior atraumatic lumbar) system.After trialing, the applicator inner shaft is installed into the applicator handle (03.812.001) and knob (03.812.004) assembly until the release button clicks into place.The appropriate spacer is attached by rotating the knob clockwise until the security ring clicks into position displaying a green band.The knob can then continue to be rotated clockwise until tight; the implant will not pivot in this position.The implant 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 implant to pivot.The implant can be advanced into the final position with light controlled hammering.Once the implant is in position, it can be detached by pushing the security ring down and simultaneously turning the applicator knob counterclockwise until it stops; the applicator can then be detached from the implanted spacer (per relevant technique guide).A review of the device history record for part # 03.812.308, lot# 8615789 revealed that no non conformance reports were generated during production and there were no issues during the manufacture of the product that would contribute to this complaint condition.(b)(4).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 28MM8MM HEIGHT
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf PA CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5936709
• MDR Text Key: 54211796
• Report Number: 2520274-2016-14464
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 08/23/2016

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
• Device Operator: Physician
• Device Catalogue Number: 03.812.308
• Device Lot Number: 8615789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 09/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2014
• 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