MAUDE Adverse Event Report: ARTHREX, INC. ATRAUMATIC HAMSTRING HARVESTER W/ FP; ORTHOPEDIC MANUAL SURG INSTR

Model Number ATRAUMATIC HAMSTRING HARVESTER W/ FP

Device Problem Dull, Blunt (2407)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 06/15/2022

Event Type  Injury  

Manufacturer Narrative

Complaint not confirmed.One ar-10300f batch # 10245244 was received for investigation.Visual investigation noticed that the harvester hook and the harvester tip have rounded edges and without any sharp edges.This device aligns with the product drawing for the intended purposes.

Event Description

It was reported that during an anterior cruciate ligament all-inside surgery the tendon stripper plucks and cuts the tendon.According to the surgeon there was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.24-jun-2022 update dw: further information were received that due to the failure the tendon was slightly damaged.However the tendon could be used to finish the surgery successfully.

• Brand Name: ATRAUMATIC HAMSTRING HARVESTER W/ FP
• Type of Device: ORTHOPEDIC MANUAL SURG INSTR
• 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: jared engle ; 8009337001
• MDR Report Key: 18666547
• MDR Text Key: 334834561
• Report Number: 1220246-2024-00842
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATRAUMATIC HAMSTRING HARVESTER W/ FP
• Device Catalogue Number: AR-10300F
• Device Lot Number: 10245244
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other