MAUDE Adverse Event Report: SYNTHES HAGENDORF STARDRIVE SCREWDRIVER SHAFT T8SELF-RETAINING/QC; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 03.617.902

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

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

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight is not available for reporting.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.Manufacturing location: (b)(4).Date of manufacture: mar 13, 2015.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently undergoing investigation.The results of the investigation are pending completion.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 during surgery to implant a zero-p device for adjacent level disc disease at c6-c7 issues occurred with two stardrive screwdrivers and a torque limiting attachment during screw insertion.The patient was previously implanted with a competitor's device one level above at c5-c6.The competitor's device remained in place as surgeon added zero-p device to the level below.While the stardrive screwdriver shaft was inside the torque limiting attachment and the torque limiting attachment was inside the standard green handle, the surgeon attempted to back out one of the screws when the stardrive screwdriver shaft began to spin freely and would not engage with the torque limiting attachment.It was noted that the distal tip of the stardrive screwdriver shaft was deformed and stripped.A second stardrive screwdriver shaft was used from the set.Retrieving the second stardrive screwdriver shaft caused a 5-7 minute surgical delay.The stardrive screwdriver shaft properly engaged the torque limiting attachment but would not allow the screw that was backed out to be screwed back down and seated.The stardrive screwdriver shaft became deformed at the distal tip.A third stardrive screwdriver shaft from another set was used.There was no reported breakage or fragments resulting from the tips of the screwdriver shafts becoming deformed.Standard x-rays were taken.The surgeon was able to properly seat the screw and complete the procedure successfully.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the screwdriver shaft t8 (part number 03.617.902, lot number 9404562).The subject device was returned with the complaint condition stating the distal drive tips were stripped.The complaint was able to be confirmed.The screwdriver shaft t8 was evaluated in a static torsional test resulting in the following conclusion: ¿the screwdriver shaft remain in the elastic range up to a torque of between 2nm and 2.2nm.The maximum of the plastic range and hence the maximum torque is achieved on the average after 2.49nm.Then the tip shears off.The tips achieve different maximum rotation angles until rupture occurs.¿ as deformation occurs between 2-2.2nm and failure occurs at approximately 2.49nm, the returned instruments were exposed to a values outside of their intended operating range causing the reported failures.Relevant drawings for the returned instrument were reviewed.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 mrrs, ncrs or complaint-related issues were identified with the lot numbers which may have contributed to the complaint condition.No definitive root cause was able to be determined; the failure mode is typically associated with rough handling and/or the application of excessive force during screw insertion.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T8SELF-RETAINING/QC
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5983510
• MDR Text Key: 55819388
• Report Number: 3003875359-2016-10517
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152239
• 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: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.617.902
• Device Lot Number: 9404562
• Other Device ID Number: (01)10705034717166(10)9404562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2015
• 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
• Treatment: ONE, UNKNOWN SCREW
• Patient Age: 55 YR