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 Problem Dull, Blunt (2407)

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

Event Date 08/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Patient weight is unknown.Additional product codes for this report include lxh.(b)(4) lot unknown.Device is an instrument and is not implanted or explanted.The complainant part is not expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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 a patient underwent a transforaminal lumbar interbody fusion (tlif) procedure from l4-s1 on (b)(6) 2016 using a transforaminal posterior atraumatic lumbar (t-pal) system.As the implant was being loaded, the push release button on the t-pal spacer applicator knob became jammed and the proximal end of the t-pal spacer applicator inner shaft became stripped.Secondary instrumentation was used to complete the procedure with a twenty (20) to thirty (30) minute delay.The patient's post-operative status was reported as stable.Concomitant devices reported: t-pal spacer applicator handle (part: 03.812.001 / lot: unknown / quantity: 1).This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: dhr review for: part # 03.812.003, lot # 9428484, manufacturing site: haegendorf, manufacturing date: 19.May 2015.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 used for treatment, not diagnosis.If in formation is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis a product investigation was completed: the returned inner shaft was examined and the complaint condition was able to be confirmed as the proximal coupling head was found to be broken and retained by the returned application knob (03.812.004).The remainder of the device was found to be intact with minimal witness marks concentrated on the distal prongs/spacer consistent with wear and tear; these marks would not inhibit device functionality.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, functional test, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.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 APPLICATOR INNER SHAFT
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• 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: 5888354
• MDR Text Key: 52496115
• Report Number: 2520274-2016-14221
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.003
• Device Lot Number: 9428484
• Other Device ID Number: (01)10705034727790(10)9428484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2015
• 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
• Patient Age: 62 YR