|
Catalog Number UNK_SEL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/13/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
|
|
Event Description
|
It was reported that there was gutter impingement medially and so the surgeon performed a gutter debridement via arthroscopic techniques.
|
|
Manufacturer Narrative
|
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A medical expert's opinion was requested in the past about the complication of gutter debridement related to ankle arthroplasty.Their statement is as follows: " in general, gutter cleaning is additional surgery which is performed quite regularly after tar (with all devices).It is associated with the procedure for sure, not necessarily related to the device used.¿ no root cause could be determined in this case, but a device related issue can nonetheless be excluded based on the statement above.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
|
|
Event Description
|
It was reported that there was gutter impingement medially and so the surgeon performed a gutter debridement via arthroscopic techniques.
|
|
Search Alerts/Recalls
|
|
|