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

Model Number	FASTPASS SCORPION-MULTIFIRE
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 11/04/2021 it was reported by a sales representative via sems that the bottom jaw of the ar-13997mf scorpion instrument, broke-off.This was discovered during use in a shoulder procedure on (b)(6) 2021.After several attempts to retrieve and remove the piece it became embedded in the surrounding shoulder capsule.The case was completed using device, a second one was not needed.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-13997mf, batch 51030 was received for investigation.Visual inspection identified that the bottom jaw of the returned ar-13997mf had fragmented at the suture slot.No fragments were returned with the main assembly for evaluation.The ar-13997mf was operated with a test needle, and did not function as intended due to the broken suture slot.The test needle was unable to be deployed through the breakage site, and became stuck at the distal tip.The cause remains undetermined, although a probable cause can be attributed to user-applied mechanical forces during use.

• Brand Name: FASTPASS SCORPION-MULTIFIRE
• 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: 12854301
• Report Number: 1220246-2021-03995
• Device Sequence Number: 5824191
• Product Code: LXH
• UDI-Device Identifier: 00888867015975
• UDI-Public: 00888867015975
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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: FASTPASS SCORPION-MULTIFIRE
• Device Catalogue Number: AR-13997MF
• Device Lot Number: 51030
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 12/14/2021
• 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