MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN PLATES; PLATE,FIXATION,BONE

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

This report is for an unk - plates/unknown lot.Part and lot numbers are unknown; udi number is unknown.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) unknown plates.This is report 6 of 9 (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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: investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.H11/d10: complainant part is not expected to be returned for manufacturer review/investigation, not available - implanted.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: UNKNOWN PLATES
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10529340
• MDR Text Key: 206795859
• Report Number: 1526439-2020-01660
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Patient Sequence Number: 1
• Treatment: MEDIUM X15 TAPERED DRIVER.; MEDIUM X15 TAPERED DRIVER.; SKY VARIABLE S-D SCW 13MM TI.; SKY VARIABLE S-D SCW 14MM TI.; SKY VARIABLE SCW CADDY.; UNKNOWN PLATES.; MEDIUM X15 TAPERED DRIVER.; MEDIUM X15 TAPERED DRIVER.; SKY VARIABLE S-D SCW 13MM TI.; SKY VARIABLE S-D SCW 14MM TI.; SKY VARIABLE SCW CADDY.; UNKNOWN PLATES.