Catalog Number IGB0665 |
Device Problems
Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/05/2022 |
Event Type
malfunction
|
Event Description
|
I want to report a complaint for a product that has just been received by a surgeon.I have tried multiple times to report this through cst and it has crashed / failed on each.Prof received some new custom made instrumentation yesterday.Prior to clinical use he inspected the kit and it¿s assembly with other parts of the instrument system.No patients were involved as the inspection was carried out in his office.He reported difficulty fully assembling two part of the new instrument kit with one part of the existing set.He reported the complaint yesterday.The affected codes in the new instrumentation kit are: igb0664, igb0665.The standard part that would not fully assemble was: 254400512.Prof does not feel that the lack of complete assembly will have little effect on the use of the instruments and does not wish to return them.
|
|
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # = > (b)(4) information was received indicating that "following further communication with the surgeon the 254400512 device was replaced with a new one from stock, this completely resolved the assembly issue with the other mating parts.Based on this, there is evidence that none of the igb0664 or igb0665 instruments are the origin of this issue." 254400512 device has been reported under 1818910-2022-09682.Due to this, depuy synthes joint reconstruction considers the device on this report to be not reportable as there is no allegation of deficiency.Further updates will only be provided if additional information is received that changes the regulatory determination.H6.
|
|
Search Alerts/Recalls
|