MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL SPACER APPLICATOR INNER SHAFT; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Catalog Number 03.812.003

Device Problems Fitting Problem (2183); Separation Failure (2547)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: there was no reported patient involvement associated with the complaint event.Additional device product codes are mnh, mni, kwq, and kwp.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.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 (b)(4) reported the following event: it was reported that during a product demonstration using the transforaminal posterior atraumatic lumbar (t-pal) instrument set, the t-pal inner shaft would not release and appeared to be jammed inside the outer shaft handle.While trailing with the t-pal instruments it was reported that the device worked once to connect and release, but when the second demonstration was attempted, the inner shaft would not release and appeared to be jammed.The spacer broke as well.This event occurred during a product demonstration only; there was no patient or procedural involvement.Concomitant device: t-pal spacer applicator knob: (item # 03.812.004, lot # unknown, quantity 1 each).This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Udi: (b)(4).Device returned to manufacturer.A product investigation was performed.The following complaint devices were received by customer quality (cq): one t-pal spacer applicator knob (03.812.004/9504972), one t-pal spacer applicator handle (03.812.001/9398032), one t-pal spacer applicator inner shaft (03.812.003/lot unk), one t-pal spacer 10mm x 28mm 7mm height (08.812.007/l303782).A visual inspection, functional test and device history review were performed as part of this investigation.This complaint is confirmed.The t-pal spacer applicator inner shaft is utilized in the t-pal system.After trialing, the applicator inner shaft is installed into the applicator handle and knob 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.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.Upon visual inspection is can be seen that the black shaft portion of the handle and the inner shaft is severely bent, preventing the device from functioning as intended.The three devices were functionally tested and the devices would not be released/separated (03.812.001,.003,.004) due to the damage to shaft.The implant was returned with a portion broken off and was not returned.The broken fragment is approximately 6.06mm to 6.16mm in length.The complaint condition could not be replicated as the shaft is already bent and the implant is already broken.Relevant drawings were reviewed.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A dhr (device history record ) review could not be done for the inner shaft (03.812.003) could not be done as the lot number could not be determined.A definitive root cause was unable to be determined however the failure mode is consistent with the application of off axis loading or rough handling.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.During the manufacturer investigation process it was identified that initially reported concomitant device applicator knob (reported on (b)(4)) is not a concomitant device.This device is now determined as the reportable device.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

This is report 1 of 4 for complaint (b)(4).

• Brand Name: T-PAL SPACER APPLICATOR INNER SHAFT
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6473487
• MDR Text Key: 72277946
• Report Number: 3003875359-2017-10175
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151276
• 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: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2017
• 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
• Treatment: 03.812.004, T-PAL SPACER APPLICATOR KNOB