MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

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.

• Brand Name: TRULIANT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15769699
• MDR Text Key: 304505656
• Report Number: 1038671-2022-01437
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862304162
• UDI-Public: 10885862304162
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 2.5 9MM
• Device Catalogue Number: 02-022-35-2509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/10/2022
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Other
• Patient Sex: Female