MAUDE Adverse Event Report: SYNTHES BRANDYWINE 4.5MM TI CANCELLOUS POLYAXIAL SCREW 30MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.614.230

Device Problem Break (1069)

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

Event Date 07/03/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Additional product codes: kwp, mnh, mni.Implant and explant dates: device malfunctioned intra-operatively and was not implanted / explanted.Initial hospital contact telephone: (b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review for part 04.614.230 , lot 7942697.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacture location: (b)(4).Manufacture date: 9-mar-2015.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported during an unknown spinal procedure on (b)(6) 2017, while surgeon was inserting the 4.5mm titanium cancellous polyaxial screw 30mm at c2, the screw became stuck.When surgeon attempted to remove it by turning the screwdriver counter-clockwise, the collet was broken and the screw head was separated from the screw shaft.Surgeon carefully removed the screw utilizing a t15 screwdriver, and then replaced it with a 26mm screw.No fragments were found in the patient.Surgery was completed successfully with a delay of approximately 5 minutes and no harm to patient.Concomitant devices reported: t15 screwdriver (part number unknown, lot number unknown, quantity 1).This report is for one (1) 4.5mm titanium cancellous polyaxial screw 30mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device.It was reported that while the surgeon was inserting the pedicle screw at area c2, the screw got stuck.He tried to remove the screw by turning a screw driver counter-clockwise, however, the collet was broken and the head was separated from the screw.The surgeon carefully removed the screw in question by using a screw driver t15, and then replaced the screw with the screw of 26mm.There were no broken parts found inside the body.The surgery was successfully done with a 5-minute delay and there was no adverse consequence to the patient.The 30mm long 4.5mm ti cancellous polyaxial screw (04.614.230, lot 7942697) is utilized in the synapse system for posterior stabilization of the upper spine.The system allows for stabilization from the occiput to the lower spine utilizing polyaxial screws, clamps/hooks and titanium rods.Specific instructions for screw insertion, including screwdriver construct assembly, are provided in the system technique guide.The returned implant was examined and the complaint condition was confirmed as the polyaxial head of the screw was returned detached from the screw body.Minor wear was noted on the screw¿s drive recess consistent with attempted implantation-explantation.The bushing component was observed to be stretched which is most probably due to excessive force applied on the polyaxial head, separating it from the screw.No broken or missing fragments hence polyaxial screw got disassembled and did not break during the operation.No definitive root cause was able to be determined for the polyaxial head detachment; however, it is likely that surgical technique contributed to the device failure.Relevant drawings for the returned implant were reviewed: top-level drawing and screw body drawing (mfg & current).The diameter of the screw head was measured to be 4.67 mm which is within the specification of 4.69 mm +/- 0.02 (per drawing).The design, materials and finishing processes were found to be appropriate for the intended use of these devices.Caliper used.No definitive root cause was able to be determined for the polyaxial head detachment; however, it is likely that surgical technique error such as excessive force may have contributed to the device failure.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5MM TI CANCELLOUS POLYAXIAL SCREW 30MM
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6756669
• MDR Text Key: 81504054
• Report Number: 2530088-2017-10243
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 07611819969230
• UDI-Public: (01)07611819969230(10)7942697
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.614.230
• Device Lot Number: 7942697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 08/01/2017
• Supplement Dates Manufacturer Received: 08/14/2017
• Supplement Dates FDA Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: T15 SCREWDRIVER (PART AND LOT UNKNOWN, QTY 1)