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

Model Number	SCORPION-MULTIFIRE NEEDLE
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/13/2020
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 that during a rotator cuff repair the surgeon had two ar-13995n scorpion needles that had issue and broke off during the case.The lot number for both needles was lot 10674580 and came from the same box.According to the staff, the first needle tip was retrieved but the second needle tip was not.It was reported that it is presumed to have been suctioned away with the neptune machine, but is not confirmed.The case was completed as planned.The facility did not save the broken needles.Two needles were used which had issue and are not available to return.One from opened box was opened by the facility to view the needle and use for comparison to confirm device retrievals and is not available to return.2 remain in the opened box.The facility will return the opened box with the two unopened needles and is seeking credit for a total of 5 needles.

• Brand Name: SCORPION-MULTIFIRE NEEDLE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10337560
• Report Number: 1220246-2020-01988
• Device Sequence Number: 17081054
• Product Code: MDM
• UDI-Device Identifier: 00888867283985
• UDI-Public: 00888867283985
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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 Expiration Date: 02/28/2025
• Device Model Number: SCORPION-MULTIFIRE NEEDLE
• Device Catalogue Number: AR-13995N
• Device Lot Number: 10674580
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other