MAUDE Adverse Event Report: SYNTHES USA 8.0MM TI SIDE-OPENING ILIAC SCREW 100MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 498.874

Device Problem Fitting Problem (2183)

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

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).(b)(4).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.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn.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 on (b)(6) 2016, the surgeon was performing a t10-ilium posterior spinal fusion with synthes uss on the patient to treat degenerative scoliosis.Near the completion of the case, the surgeon was connecting the left iliac screw to the rod using the rod introduction pliers.He had difficulty getting the rod to persuade into the side opening of the screw.While using the persuader, the inner portion of the stick sheared off and broke.This left the threaded part of the stick in the screw implant.The surgeon removed this implant with a uss rod holder and placed a new screw.The exact same thing happened again.He removed this screw in the same manner.As a result, there was a ten (10) minute surgical delay.The broken device fragments were removed easily without additional intervention.The surgeon recannulated the ilium and placed a new screw in a slightly different trajectory.He was able to connect this screw to the rod successfully.There was no harm to the patient and the procedure was successfully completed.This complaint involves four (4) devices.This report is 3 of 4 for (b)(4).

Manufacturer Narrative

A product investigation was completed: during the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.The hook or screw holder (338.61) is noted in both the uss and the uss vas system technique guides.In each system the device is utilized for placement of screws and hooks in the uss system.The returned holders were examined and the complaint conditions were able to be confirmed in each instance as the threaded tips of both devices were found to be broken off.One threaded tip was returned separate, while the second was found to be retained by a returned screw.No definitive root cause was able to be determined; the failure mode is typically associated with the application of off-axis loading leading to device failure.Two 8.0mm iliac screws (498.874) were also returned without allegation.The returned screws were examined and one was found to have retained the broken threaded tip of a hook or screw holder.Additionally both implants show wear consistent with implantation and explantation.Relevant drawings for the returned instruments were reviewed (both from the time of manufacture and present revision): top-level and stem.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned instruments' lot numbers and no material review reports or complaint-related issues were identified with the lot numbers which may have contributed to the complaint condition.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: 8.0MM TI SIDE-OPENING ILIAC SCREW 100MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5706654
• MDR Text Key: 46815506
• Report Number: 2520274-2016-13062
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082572
• 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: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 498.874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR