MAUDE Adverse Event Report: SYNTHES HAGENDORF STARDRIVE SCREWDRIVER SHAFT T8 SELF-RETAINING/QC; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 03.617.902

Device Problems Dull, Blunt (2407); Material Deformation (2976)

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

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Manufacturing site: (b)(4).Manufacturing date: july 18, 2014.No non-conformance reports 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported that on (b)(6) 2016, during zero-p stand alone spacer surgery to correct stenosis at the c5-c6 level, the tip of a stardrive self-retaining screwdriver shaft was twisted and stripped while advancing a screw.A replacement was immediately supplied and no delay in surgery was noted.The same screw was used successfully without malfunction.There was no harm to the patient.Patient status / outcome was reported as unknown.The procedure was completed successfully.Concomitant devices reported: 3.0mm titanium (ti) cervical spine locking screw 16mm (part 04.617.816, lot unknown, quantity 1).This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Additional narrative: product investigation was completed.One stardrive screwdriver shaft t8 (03.617.902 lot 8973747) was returned or investigation.A visual inspection, functional test, and drawing review were performed as part of this investigation.The returned instrument was examined and the complaint condition was able to be confirmed as the distal drive tip was found to be stripped.The screwdriver shaft t8 (03.617.902) was evaluated in a static torsional test resulting in the following conclusion: ¿the screwdriver shafts 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.¿ through the testing two of four tips deformed, another sheared partially and the final sheared completely.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 instrument¿s lot number and no manufacturing records reviews, non conformance reports or complaint-related issues were identified with the lot number 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.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: STARDRIVE SCREWDRIVER SHAFT T8 SELF-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: 5888796
• MDR Text Key: 52522955
• Report Number: 3003875359-2016-10453
• 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,Followup
• Report Date: 08/02/2016

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: 03.617.902
• Device Lot Number: 8973747
• Other Device ID Number: (01)10705034717166(10)8973747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2014
• 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: 53 YR