MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH SURGICAL INSTRUMENT TRAY; ORTHOPEDIC TRAY

Model Number SPECIFIC DEVICE NOT REPORTED

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437)

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

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation with the surgical site is ongoing and the product is expected to be evaluated by exactech and qmed to determine root cause and any corrective actions needed.Additional information will be submitted via supplemental reports within 30 days of receipt.

Event Description

It was reported by a surgery center that, ¿it appears an [rfid] tracker from quest [qmed] was on the tray and ¿exploded¿ in the sterilizer during the sterilization process.The instruments, outer wraps, and sterilizer all appear to have been damaged.¿ the qmed tracker was affixed to the exactech tray on (b)(6) 2020.The tray was deployed to the surgical center on (b)(6) 2021.A review of the tracker log confirmed that this kit was sterilized at the same site two times prior to this event ((b)(6) 2021 and (b)(6) 2021) without incident.It is unknown at this time if the same sterilizer was used for the cycles prior to this event.Additional information received indicates that the steris autoclave model used was a 1563v-1.The tray was cleaned prior to being loaded into the sterilizer using a steris automatic washer (amslu# fh19403), a prolystica enzymatic detergent, prolystica lube and prolystica neutral detergent.There were no anomalies noted with the tray prior to putting it on the autoclave.The instrument tray was loaded into the sterilizer on the top rack, mid back of the left side at 2:01:56 pm on (b)(6) 2021.The sterilizer had a full load (15 trays).As evidenced by the sterilizer report, the load completed a full sterilization cycle and exhaustion cycle without interruption or alarms (49 mins, 38 seconds total time).The max temperature was 271.8-degrees fahrenheit.No one at the surgical site heard any noises or smelled anything abnormal coming from the sterilizer during the cycle.The door to the sterilizer was opened at 2:52:26 pm.Protective equipment (ppe) was worn by the staff while removing the tray from the sterilizer per the surgical center¿s internal procedures.No anomalies were noted when the trays were removed from the sterilizer.The failure was noted on (b)(6) 2021.Upon opening the sterile wrap, the tracker was found to be fragmented and there were pieces within the sterile wrap.All pieces were contained within the wrap.There was discoloration, charring and residue leak on the inside of the sterile wrap, presumably from the discharge of internal battery components/material.The instruments within the tray were damaged by staining, charring and residue.The elective total knee arthroplasty was rescheduled to take place at another local hospital and was performed by the same surgeon.While the patient did experience a delay of the surgery and inconvenience, there was no patient injury and no reported injury to any users.It is unknown at this time if the sterilizer was used for any subsequent sterilization loads in the time that elapsed between when the event occurred and when the issue was discovered.The sterilizer was evaluated by the staff and it was noted that there was discoloration on the rack in the location where the affected tray had been during the sterilization cycle.Additionally, there is a residue left inside the sterilizer in places where the staff cannot reach to clean it.Steris was called in to evaluate, service and clean the sterilizer.At this time, it remains out of use.Based on the available information it appears that the reported ¿explosion¿ was actually the overheating and thermal decomposition (imdrf a1005 and a1006) of the lithium ion battery inside the tracker.There is no evidence of a true explosion (a violent bursting due to the sudden expansion of air, gas or fluid).The investigation with the surgical site is ongoing and the product is expected to be evaluated by exactech and qmed to determine root cause and any corrective actions needed.

Manufacturer Narrative

After further review of additional information received the following sections date rec¿d by mfr, if follow-up, what type, device evaluated by mfr and adverse event problem have been updated accordingly.The evaluation noted that revision reported was likely the result of overheating and thermal decomposition of the qmed rfid tracker during sterilization, which led to damage of the instrument tray, the instruments within the tray, and the sterilizer.However, the tracker has been sent to qmed for additional analysis.The most probable root cause associated with the reported event of "corroded" is associated with one device causing harm to another device.

• Brand Name: EXACTECH SURGICAL INSTRUMENT TRAY
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11406913
• MDR Text Key: 239181695
• Report Number: 1038671-2021-00088
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: KIT-271A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1