WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM TI MATRIXRIB LCKNG SCREW SELF-DRILLING/8MM - STERILE; PLATE, FIXATION, BONE
|
Back to Search Results |
|
Catalog Number 04.501.208.01S |
Device Problem
Migration (4003)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/01/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
This report is for an unk - screws: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.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
|
It was reported that during an unknown procedure on (b)(6) 2020, the matrix sub joint screws size 8 mm has pulled off of 2 plates.The reported screws pulled away from the bone.The surgeon decided not to revise issue.It is unknown if there was a surgical delay.There was no patient consequence reported.Surgical outcome is unknown.Concomitant device reported: unknown plated (part # unknown, lot # unknown, quantity 2).This complaint involves 1 device.This is report 1 of 1 for (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.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) 2020, five (5) matrixrib locking screws were noticed to have pulled off of two (2) matrixrib plates.The reported screws pulled away from the bone.The issue was discovered via imaging the next day after the procedure.Initially, the reported screws were implanted on (b)(6) 2020.The surgeon decided not to revise issue.There was no patient consequence reported.Concomitant devices reported: ti matrixrib pre-contoured plate 18 holes for left ribs 8 & 9 (part # 04.501.007, lot # unknown, quantity 2); 2.7mm ti matrixrib locking screw self-drilling/8mm-sterile (part # 04.501.208.01s, lot # unknown, quantity 4).This report is for one (1) 2.7mm ti matrixrib locking screw self-drilling/8mm-sterile.This is report 1 of 5 for complaint (b)(4).
|
|
Search Alerts/Recalls
|
|
|