MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number LOGIC TIBIA PS MOD INSRT SZ 3 9MM

Device Problem Contamination (1120)

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

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported, during an initial procedure, when the implant was opened, a fiber was observed when cutting the last bag of the packaging and therefore it is discarded.Patient was last known to be in stable condition following the event and there was no delay in the procedure.The device will be returned for analysis.All available information has been received.

Manufacturer Narrative

(h3) the evaluation noted that based on the investigation conducted as part of an internal risk analysis 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 in the fmea.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.Based on risk analysis, 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.However, the reported complaint was manufactured/used prior to implementation of corrective actions section d9: device available for evaluation.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11543062
• MDR Text Key: 251418368
• Report Number: 1038671-2021-00123
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862001801
• UDI-Public: 10885862001801
• Combination Product (y/n): N
• PMA/PMN Number: K033883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

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 Expiration Date: 05/09/2022
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 3 9MM
• Device Catalogue Number: 02-012-35-3009
• Device Lot Number: 6103827
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/22/2021
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1