MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC SCREW INSERTER T8 SELF-RETAINING/QC; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Model Number 03.617.904

Device Problems Material Twisted/Bent (2981); Naturally Worn (2988)

Patient Problem Not Applicable (3189)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Additional device code: kwq.Device is an instrument and is not implanted / explanted.The device was received and the product evaluation is in progress.No conclusion can be drawn.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) 2017, patient underwent initial anterior cervical discectomy fusion procedure.During the surgery, while placing zero p va screws, surgeon had some difficulty with the drivers.The two drivers were worn out and the two handles were squeaking.As no additional screwdrivers were readily available or use, the surgeon changed to depuy spine skyline plate and screws and used a synthes acis interbody spacer.There was 5 minutes delay in procedure.Procedure was completed successfully and patient was reported as stable post operatively.There was no patient harm reported.Concomitant device reported: zero p va screws (part # unknown.Lot # unknown, quantity - unknown).This report is for one (1) screw inserter t8 self-retaining/qc.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Part 03.617.904, lot 9369998: manufacturing location: (b)(4).Release to warehouse date: february 26, 2015.No non-conformance reports were generated during production.Review of the device history records (dhr) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was completed: per the technique guide, the screw inserter, t8, self-retaining, quick coupling (03.617.904) is one of four t8 screw insertion drivers in both the zero-p and zero-p variable angle (va) systems.The zero-p system notes that a 1.2 nm torque limiting attachment (03.110.002.99) must be used for screw insertion, cautioning: if the torque limiting attachment is not used, breakage of the driver may occur, potentially increasing risk to the patient.When inserting screws in the va system, no torque limiting attachment is necessary as the screw head is retained by a blocking mechanism once fully inserted.The returned instrument was examined and the complaint condition was able to be confirmed as the distal tip was found to be worn with the lobes deformed.No definitive root cause was able to be determined however the failure mode is typically associated with wear and tear and/or the application of loading while not fully engaged into the screw drive recess.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture.The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis possible due to post-manufacturing damage.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number and no material review reports, non-conformance reports or complaint-related issues were identified with the lot number which 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: SCREW INSERTER T8 SELF-RETAINING/QC
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7072622
• MDR Text Key: 93422036
• Report Number: 8030965-2017-50204
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 10705034717180
• UDI-Public: (01)10705034717180(10)9369998
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.617.904
• Device Catalogue Number: 03.617.904
• Device Lot Number: 9369998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 56 YR