MAUDE Adverse Event Report: SYNTHES SELZACH 4.0MM TI CANCELLOUS POLYAXIAL SCREW 22MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.614.122S

Device Problem Break (1069)

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

Event Date 07/02/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient identifier and weight not available for reporting.Additional product codes: kwp, mnh, mni.Udi: (b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Hospital contact address, postal code, and telephone not available for reporting.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review for sterilization procedure: no ncrs were generated during production.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.Manufacturing location: (b)(4).Supplier: (b)(4) manufacturing date: 13.Apr.2011 expiry date: 01.Mar.2021.Non-sterile 04.614.122 / 6620612 was manufactured in us.Dhr review for non-sterile 04.614.122, lot 6620612.No ncrs or scrap were generated during production.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 action.Manufacture site: (b)(4).Manufacture date: 10-mar-2011.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 patient underwent an emergency surgery for a burst fracture at c5 in which the synapse 3.5 system was used.The implant area was c4-c7 for a posterior cervical spinal fusion.Surgeon inserted the 4.0mm polyaxial screw and confirmed the joining angle between the insertion angle of the screw and the screw head was unusual.Under imaging surgeon confirmed that a screwdriver would grab the reported screw properly.As surgeon brought the screw back to a previous position, he noted that the screw was separated from the screw head.Surgeon replaced the broken screw with another new screw.Surgeon encountered the same insertion angle issue when attempting to insert a 3.5mm cancellous screw, and also noted that the polyaxial moving parts got stuck and the head did not move properly.This screw was also replaced with another new screw.Surgeon noted patient was well-muscled due to his age, which may have prevented the screwdriver from keeping the proper insertion angle.Surgery was completed successfully with a delay of approximately 90 minutes and no harm to patient and no fragments generated.Concomitant devices reported: screwdriver (part number unknown, lot number unknown, quantity 1).This report is for one (1) 4.0mm cancellous polyaxial screw 22mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device returned to manufacturer.The device has been 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.

Manufacturer Narrative

Manufacturing evaluation was completed.The 04.614.022 was received with screw attached but frozen to the body assembly.On the screw, there is raised metal on the face of the t15 stardrive.The t15 stardrive lobes are sheared and at the bottom of the stardrive pocket there is an indentation where metal has been displaced.The screw has soft tissue visible on the neck near spherical diameter.In the cut-out area below the thread has burnishing for approximately 20% on the bottom surface.The screws spherical outer diameter is perceived to be centered on the edge of the bushing rather than being center in bushings spherical inner diameter.The bead blasted area of the screw is visibly polished.All described nonconformities/damage would be post manufacturing.Device history records (dhr) review showed that the components relevant features were manufactured to top level print specifications.Features are unobtainable on bushing after being split and the screws spherical diameter applies after anodize but prior to bead blast.The raw materials on the relevant components are also unobtainable due to their small surface area, but dhr review showed that the correct raw material was used for each of the components.Review of the final assembly inspection sheet showed a 100% functional check was completed and the screws were retained and free to articulate.Since all features relevant to complaint condition are unobtainable, but meet specification per device history records review, complaint is confirmed that screw is frozen in the bushing in the body assembly; but, unconfirmed from a manufacturing perspective.No product related issue could be identified.We are not able to identify the exact root cause for the reported problem.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

Manufacturing evaluation was completed.The 04.614.122 was received with screw not attached to the body assembly.On the screw, there is a nick on the backside of the cutting flute.There is raised metal on the face of the t15 stardrive.The t15 stardrive lobes are sheared and at the bottom of the stardrive pocket there is an indentation where metal has been displaced.The bushing has two dents on the face with blood and soft tissue visible.In the cut-out area below the thread has burnishing for approximately 25% on the bottom surface.All described nonconformities/damage would be post manufacturing.Device history records (dhr) review showed that the components relevant features were manufactured to top level print specifications.Features are unobtainable on bushing after being split and the screws spherical diameter applies after anodize but prior to bead blast.The raw materials on the relevant components are also unobtainable due to their small surface area, but dhr review showed that the correct raw material was used for each of the components.Review of the final assembly inspection sheet showed a 100% functional check was completed and the screws were retained and free to articulate.Since all features relevant to complaint condition are unobtainable, but meet specification per device history records review, complaint is confirmed that screw is detached from body assembly; but, unconfirmed from a manufacturing perspective.No product related issue could be identified.The exact root cause could not be determined for the reported problem.Manufacturing evaluation for part 04.614.022 was inadvertently reported in the (b)(4).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: 4.0MM TI CANCELLOUS POLYAXIAL SCREW 22MM
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6751837
• MDR Text Key: 82043342
• Report Number: 3000270450-2017-10268
• Device Sequence Number: 1
• Product Code: NKG
• 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,Followup,Followup
• Report Date: 07/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: 04.614.122S
• Device Lot Number: 3763783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20 YR