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

Catalog Number 03.812.004

Device Problem Fitting Problem (2183)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 05/23/2016

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.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 expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).(b)(4).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

Device report from synthes europe reports an event in the (b)(6) as follows: it was reported that a surgeon encountered difficulties inserting a peek cage during a surgical procedure on (b)(6) 2016.During the procedure, the surgeon successfully placed the trial implant and loaded the peek cage onto the introducer, but then encountered problems when attempting to remove the applicator shaft from the cage.The surgeon attempted to remove the silver applicator knob and the outer shaft in an effort to resolve the problem, but the inner shaft remained stuck in the patient.The use of a burr to detach the shaft was not possible due to poor visibility.After forty-five (45) minutes of effort, the surgeon was required to use excessive force.Once the shaft was removed, it was noted that the prongs on the end of the inner shaft, which grip the cage during insertion, had splayed.One (1) of the prongs had actually snapped off.The cage remained successfully implanted, but the procedure was extended by a full hour due to the intra-operative events.This report is 3 of 4 for (b)(4).

Manufacturer Narrative

Manufacturing location: (b)(4).Manufacturing date: october 3, 2011.No non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

The patient status/outcome was reported as absolutely fine.

Manufacturer Narrative

A product evaluation was performed.The investigation of the complaint articles indicates that: the devices were received in a disassembled state.The applicator knob (03.812.004) shows normal signs of wear and tear.The applicator outer shaft (03.812.001) shows strong signs of wear and tear.The damage as seen on the parts originates from extraction of jammed inner shaft.The jamming was most likely generated by either a too steep angle of the approach or over-rotating of the peek cage or both.The surgical technique states clearly that an angle of minimum 10° from sagittal plane must be kept.On the proximal section traces are visible where an unknown instrument has broken the surface.Along the surface of the interface of the holder with the implant/trial implant indentations are noticed.The applicator inner shaft (03.812.003) arrived in two pieces and bent.Where the shaft splits in two fork arms, one arm is broken off and the other is bent away from the midline.The broken off part shows strong signs of wear on the inner side.The bent part shows strong signs of wear on the outside.The peek cage used for this procedure was not sent back, because it is still implanted in the patient.The jamming was most likely generated by either a too steep angle of the approach or over-rotating of the peek cage or both.No product related issue could be detected.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.

• Brand Name: T-PAL SPACER APPLICATOR KNOB
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5691433
• MDR Text Key: 46288436
• Report Number: 2520274-2016-12960
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.004
• Device Lot Number: 7577972
• Other Device ID Number: (01)07611819414624(10)7577972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2011
• 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 Outcome(s): Required Intervention