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

Model Number	SCORPION-MULTIFIRE, HUMPBACK
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device is expected but was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the suture was not moved forward during a surgery, they have tested the device afterwards and it worked there.Additional information obtained 7/16/18: the performed surgery was an shoulder arthroscopy.Because of the incident the surgeon needed to do a bigger cut and also the surgery took 10 minutes longer then expected (initial surgery time 1 hour).The surgery was completed successfully with a changed technique - from arthroscopy to open.
Additional Manufacturer Narrative
The evaluation did not reveal anything relevant to the event.The mating part (needle) was not returned along with complaint device.Used an ar-13995n/lot#1491051z needle during evaluation.

• Brand Name: SCORPION-MULTIFIRE, HUMPBACK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7734640
• Report Number: 1220246-2018-00579
• Device Sequence Number: 1018814
• Product Code: LXH
• UDI-Device Identifier: 00888867015944
• UDI-Public: 00888867015944
• 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,Followup
• Report Date (Section B): 07/15/2021

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, HUMPBACK
• Device Catalogue Number: AR-13995
• Device Lot Number: 32621
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 07/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other