WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM; PLATE,FIXATION,BONE
|
Back to Search Results |
|
Model Number 02.107.302 |
Device Problem
Device-Device Incompatibility (2919)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/04/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional procode: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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, an unknown locking screw wouldn't lock into the most proximal screw holes of the reported variable angle locking compression plate (va-lcp) olecranon plate.The procedure was completed by leaving the locking screw in the screw hole unlocked.There was a 2 minute surgical delay reported.Patient status is unknown.This complaint involves 2 devices.This report is for 1 2.7mm/3.5mm va-lcp olecranon pl 2h/lt/90mm.This is report 1 of 2 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.
|
|
Search Alerts/Recalls
|
|
|