Model Number BTB TIGHTROPE W/ DEPLOYING SUTURE |
Device Problem
Physical Resistance/Sticking (4012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/27/2023 |
Event Type
malfunction
|
Event Description
|
On (b)(6) 2023, it was reported by an arthrex employee via email that an ar-1588btb-j btb tightrope had an issue.The doctor felt resistance at the chinese finger trap part when assembling.They used a new product, and the case was completed.No patient harm.No case involvement.
|
|
Manufacturer Narrative
|
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
|
|
Search Alerts/Recalls
|