Catalog Number NL4258-84T |
Device Problem
Break (1069)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/27/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Pr # (b)(4).On (b)(6) 2020 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.
|
|
Event Description
|
Per email: tip of instrument was broken during procedure.Was product used on patient? yes.Did the failure occur during patient use? yes.Was there any patient harm? no.Medical intervention required? no.Was there any user harm? no.No further information available.
|
|
Event Description
|
Per email: tip of instrument was broken during procedure.Was product used on patient? yes.Did the failure occur during patient use? yes.Was there any patient harm? no.Medical intervention required? no.Was there any user harm? no.No further information available.
|
|
Manufacturer Narrative
|
The product was returned, and an evaluation was performed.The root cause of the reported issue is that the instrument has been reworked by an unauthorized 3rd party repair.Hardness is 46.6 hrc (inside the tolerance 43-48 hrc).A review of the material batch found no irregularities.The device was subjected to a microscopic examination.Marks on the slider and on the screw indicate improper repair by an unauthorized repair company.It appears that the foot plate was grinded by the repair site, reducing material stability and thus increasing the risk of breakage.The foot plate cannot be checked because this piece is missing.The customer confirmed that the tip was removed from the patient.There have been no issues identified with the material or manufacturing process.The product has been manufactured and tested according to the specifications.A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.
|
|
Search Alerts/Recalls
|