MAUDE Adverse Event Report: ARTHREX, INC. APOLLORF HOOK, NON-ASPIRATING 90°; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number APOLLORF HOOK, NON-ASPIRATING 90°

Device Problem Energy Output Problem (1431)

Patient Problems Unspecified Infection (1930); Laceration(s) (1946); Muscle Weakness (1967); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Superficial (First Degree) Burn (2685); Muscle/Tendon Damage (4532)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported by legal counsel that on (b)(6) 2020 the patient injured his left wrist while carrying lumbar.Thereafter on (b)(6) 2020 the patient underwent surgery on his left wrist.During the surgery the surgeon utilized the ar-9825 which resulted in unintended burns to the patient.Following the surgery the patient suffered injuries to multiple extensor tendons in or around his left wrist near the location of the original surgery site.On (b)(6) 2021 the surgeon performed a second surgery to address the tendon injuries.Following the second surgery the patient developed an infection in his left wrist near the location of the surgery site.On (b)(6) 2021 an i&d was performed.On (b)(6) 2021 a second i&d was performed and suture material was removed.The patient was referred to an infectious disease doctor and ultimately sought a second opinion.On (b)(6) 2021 a different surgeon performed surgery to reconstruct the patients ruptured left ring and small finger extensor tendons which were allegedly injured as a result of the initial surgery.Finally in (b)(6) 2022 the second surgeon performed another surgery to remove scar tissue and shave down bones in the patient¿s left wrist.Despite the multiple surgeries the patient continues to have pain in his left wrist, inability to extend his wrist and popping and weakness in his ring and small fingers.

• Brand Name: APOLLORF HOOK, NON-ASPIRATING 90°
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16050766
• MDR Text Key: 306167006
• Report Number: 1220246-2022-05952
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: APOLLORF HOOK, NON-ASPIRATING 90°
• Device Catalogue Number: AR-9825
• Device Lot Number: S170152
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/27/2022
• Date Device Manufactured: 05/25/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other