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

Model Number	MULTIFIRE SCORPION NEEDLE
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/10/2019
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 intra-operatively, the needle tip broke off.The surgeon tried to remove the broken fragment but it was not possible.The fragment will remain inside the patient.The surgery was completed successfully with a new device of the same part number.It is not possible for the customer to send back the needle for evaluation because he lost the device in-house.No further information received.

• Brand Name: MULTIFIRE SCORPION NEEDLE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9193627
• Report Number: 1220246-2019-01361
• Device Sequence Number: 18929385
• Product Code: MDM
• UDI-Device Identifier: 00888867283985
• UDI-Public: 00888867283985
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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: 06/30/2023
• Device Model Number: MULTIFIRE SCORPION NEEDLE
• Device Catalogue Number: AR-13995N-1
• Device Lot Number: 10223338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other