ARTHREX, INC. IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
|
Back to Search Results |
|
Model Number IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH |
Device Problems
Break (1069); Connection Problem (2900); Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/28/2021 |
Event Type
malfunction
|
Event Description
|
On (b)(6) 2021, it was reported by a sales representative via sems that while in a tka case the silver base on collared handle (ar-613-1) came off during keel punch removal, we attached the second handle to remove punch and continued with procedure, also during this procedure the poly impactor (ar-613-98) would not easily connect to the handle.The tech used a mallet to get it onto handle.All broken pieces were retrieved, and the was no patient effect reported.
|
|
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
|
|
|