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

Model Number	SCORPION-MULTIFIRE
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported during a rotator cuff repair procedure as the surgeon was passing sutures through the cuff, they realized that a piece of the jaw on the ar-13996 multifire scorpion was missing.The surgeon proceeded to look for the broken fragment.An x-ray was called and confirmed the broken piece was in the patient's shoulder.After many attempts, the surgeon decided to leave the piece due to it being far back with the repair.The rep reported no unplanned incisions were made.The procedure was the first case of the day, and the facility usually keeps two scorpions in their tray.The lot number of the complaint device is unknown.The complaint device is currently being held by the hospital's risk management department.It is currently unknown if the surgeon plans to perform a second surgery.Additional information received on 01/30/2020: the rep received confirmation from the surgeon that a second surgery will not be performed.

• Brand Name: SCORPION-MULTIFIRE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9695545
• Report Number: 1220246-2020-01657
• Device Sequence Number: 1743011
• Product Code: LXH
• UDI-Device Identifier: 00888867015968
• UDI-Public: 00888867015968
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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
• Operator of Device: Health Professional
• Device Model Number: SCORPION-MULTIFIRE
• Device Catalogue Number: AR-13996
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other