MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; LOGIC CC FEMORAL SIZE 4, RIGHT

Catalog Number 02-010-06-0340

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

As a result of an fda inspection conducted in (b)(6) 2020, exactech, fei 1038671, has committed to remediating 3 years of complaints (2017-2020).This mdr is being submitted as part of that remediation.The device was available for analysis.Engineering analysis completed by mb on (b)(6) 2019.Design-related issues: exactech is aware of 18 complaint reports involving 19 femoral components due to inner packaging damage since 2008.Sales data for femoral components was used to calculate an approximate complaint occurrence rate of <0.5%.This is considered ¿very low¿ according to the frequency of occurrence ranking scale.Therefore, this issue does not appear to be design related.Mfg-related issues: exactech is not aware of any other complaints involving parts from this manufacturing lot.A sibling device was evaluated, and all inner packaging was intact.See visual evaluation section above.Therefore, this issue does not appear to be manufacturing related.A review of the risk management report (rmr) was conducted to ensure the risk was included and the occurrence is below the threshold.The rmr for this logic cc femoral component, 750-2011-032-rmr-implants rev e, was reviewed.The risk is captured in line 13.Corrective actions are not required because the occurrence rate is ¿very low¿, and the risk is captured in the rmr.A crc was held regarding this issue.See (b)(4) no field action will be taken at this time.The inner packaging damage reported in experience (b)(4) was likely the result of a high energy event during transportation or handling of the device packaging, which led to the femoral flange puncturing or wedging past the inner foam sheet and puncturing both tyvek lids.Ifu states: the surgeon shall become thoroughly familiar with the technique of implantation of the prostheses by: appropriate reading of the literature, and training in the operative skills and techniques required for surgery, and reviewing information regarding use of instrumentation.It is a clinical standard of practice in the operating room that all instruments should be visually and functionally inspected before use, these guidelines are from standard association of peri-operative registered nurses (aorn) guidelines.Surgeons are to be familiar and knowledgeable with all instrumentation, devices and proficient with surgical techniques.All packaging for instruments and implants should be closely inspected for damage and sterile integrity.This device is used for treatment not diagnosis.Based on review of all available information, there is no evidence to reasonably suggest the reported event is related to any manufacturing issues or design issues.There is no reported patient adverse event.The loss of implant sterility poses a threat of patient infection.All packaging for instruments and implants should be closely inspected for damage and sterile integrity.An investigation was conducted: the inner packaging damage reported was likely the result of a high energy event during transportation or handling of the device packaging, which led to the femoral flange puncturing or wedging past the inner foam sheet and puncturing both lids.

Event Description

It was reported from the us that during a revision of competitor components to exactech components; the surgeon experienced an issue with the implant packaging.During the case there was a packaging issue with the femoral component.The product was opened on the sterile field.A scrub tech noticed a hole in the packaging.The product was passed off and table re-draped.After examination of the packaging, it was found that both clear packages had a hole in them.The outer box was wrapped in plastic (not compromised) and the box didn¿t have any damage or hole in it (not compromised).The reporter stated, ¿the hole in the sterile containers had to have occurred before product was put into the box and wrapped in plastic.The end result was satisfactory with no harm to the patient.¿ there was a delay to surgery, but the patient was not adversely affected.The device was received in complaints for analysis on (b)(6) 2019.The compromised sterility of the device poses potential for patient infection.No additional information has been made available.

• Brand Name: EXACTECH
• Type of Device: LOGIC CC FEMORAL SIZE 4, RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 14150541
• MDR Text Key: 289670668
• Report Number: 1038671-2022-00432
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2022

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 Catalogue Number: 02-010-06-0340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/13/2018
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR