MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKY VARIABLE S-D SCW 14MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 186850014

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 (b)(6) reports an event as follows: it was reported on (b)(6) 2020 that the patient underwent for a surgery.During the surgery, the screws were falling of the screwdriver.The scrub nurse had problems while picking up screws from the screw caddy as they were sinking into the top plastic layer where they got stuck and were hard to get out.Upon examination of the screw caddy we noticed that the top plate is elevated and the screws that are holding it in place are holding it are deformed/displaced.During the surgery (2 level), some of the screws had to be replaced with large diameter screws.Surgeon was unable to remove 3 of the screws and had to leave them in place although they were not fixated in the bone ¿ he managed to unscrew them but could not take them out of the bone/skyline plate.They had to finish the surgery with the 3 screws not fixed into the bone but locked into the plate.The procedure was completed successfully with 45 minutes delay.There were no patient consequences.This complaint involves ten (10) devices.This report is for (1) sky variable s-d scw 14mm ti.This is report 5 of 9 (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: a product investigation was completed: the screw was received in the received caddy.After removal of the screw from the caddy, no visual defects were identified on any component of the screw.The screw head showed no damage.The relevant drawing was reviewed.The overall complaint was not confirmed for the received screw as there was no damage identified that would attribute to the complained device interaction issue.The reported device interaction issue was likely caused by the damage noted to the mating screwdrivers.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d4: updated lot number h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device history lot the dhr of product code: 186850014 lot : 276765 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 30.03.2020 qty: 135 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: SKY VARIABLE S-D SCW 14MM TI
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10529351
• MDR Text Key: 206820607
• Report Number: 1526439-2020-01659
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 10705034134086
• UDI-Public: 10705034134086
• Combination Product (y/n): N
• PMA/PMN Number: K052552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186850014
• Device Catalogue Number: 186850014
• Device Lot Number: 276765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 10/26/2020
• Patient Sequence Number: 1
• Treatment: MEDIUM X15 TAPERED DRIVER; MEDIUM X15 TAPERED DRIVER; SKY VARIABLE S-D SCW 13MM TI; SKY VARIABLE SCW CADDY; UNKNOWN PLATES; UNKNOWN SCREWS; MEDIUM X15 TAPERED DRIVER; MEDIUM X15 TAPERED DRIVER; SKY VARIABLE S-D SCW 13MM TI; SKY VARIABLE SCW CADDY; UNKNOWN PLATES; UNKNOWN SCREWS