EXACTECH, INC. TRULIANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
|
Back to Search Results |
|
Model Number TRULIANT TIB IMP PS INSERT SZ 2.5 9MM |
Device Problem
Contamination (1120)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/03/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional information, including the product investigation, will be submitted within 30 days of receipt.
|
|
Event Description
|
It was reported that prior to a surgical procedure, on the back table, a black l shape object was found on the truliant insert.This object was in the evoh package.The surgeons would like to know where this object came from.No impact to a patient since this was found before surgery.Surgical delay/prolongation, less than 5 minutes.Pcs with same size insert was implanted.The device is available for return.
|
|
Manufacturer Narrative
|
The black foreign matter within sterile packaging reported may have been due to either variance in improper maintenance of ultrasonic/alcohol black polypropylene drying mats, lack of operator awareness during visual inspection, inconsistency in red zone disinfection frequency, and/or inadequately defined interim product storage/cleaning maintenance for blue and red zone packaging areas compromising product sterility of pouch sealed product.Additionally, a lack of routine training decreased awareness around contamination complaints historically investigated.
|
|
Search Alerts/Recalls
|
|
|