MAUDE Adverse Event Report: ARTHREX, INC. LABRAL SCORPION; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	LABRAL SCORPION
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the labral scorpion was used for the first time the top jaw broke off inside the patient into two pieces during firing and separated it from the rest of the handle.The broken pieces were retrieved from patient.This occurred during a shoulder arthroscopy, anterior stabilization and biceps tenodesis surgery.There was no harm for patient, operator or third party.The surgery was finished successfully with a shoulder lasso used for suture passing, which required a change in the surgical technique.It was not necessary to do a second surgery.
Additional 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.
Additional Manufacturer Narrative
Complaint is confirmed.Upon visual evaluation, it was noted that the device was damaged.The device is missing the jaw, cutter pin, fastpass trap door, and torsion spring.Also, the laser marking is faded.However, the broken pieces were not returned for investigation.The cause remains undetermined.

• Brand Name: LABRAL SCORPION
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 16386055
• Report Number: 1220246-2023-06303
• Device Sequence Number: 5618523
• Product Code: LXH
• UDI-Device Identifier: 00888867015999
• UDI-Public: 00888867015999
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: LABRAL SCORPION
• Device Catalogue Number: AR-13998
• Device Lot Number: 67755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown