MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number TRULIANT TIB IMP PS INSERT SZ 3 11MM

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, during surgical use of the truliant tib imp ps insert sz 3 11mm, a hair was noted in the device package.Patient was last known to be in stable condition following the event.The device will be returned.Patient was not effected.

Manufacturer Narrative

After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) based on the investigation conducted regarding complaints of hair in sterile packaging, inconsistencies in prevention methods were found such as use of ppe at handling and detection methods, such as standard inspection process for identifying the existing visual inspection criteria.No environmental control was found to ensure lighting is consistent at inspection points and review of training records show there is no standard method to document confirmation of operator ability to detect this particular defect.Additionally, the risk of foreign particulate or hair in the package was not identified.Although reported to have been noticed upon opening of the inner packaging, the complaint device was returned without intact sterile packaging so the presence of the hair inside the packaging prior to opening the implant cannot be confirmed.The hair within sterile packaging reported was likely the result of a lack of standardization around variables (process, lighting, ppe) pertaining to material handling and visual inspection.A risk assessment has been initiated to escalate this issue.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3 11MM
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12908964
• MDR Text Key: 281528969
• Report Number: 1038671-2021-00647
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862304278
• UDI-Public: 10885862304278
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/17/2022

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 3 11MM
• Device Catalogue Number: 02-022-35-3011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1