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

Model Number	SCORPION-MULTIFIRE, HUMPBACK
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
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 11/27/2023, it was reported by a sales representative via (b)(4) that an ar-13995 multifire scorpions top jaw was cracked.This occurred during a case, with no effect on the patient.
Additional Manufacturer Narrative
The complaint was confirmed.One unpacked ar-13995 serial/batch number (b)(6) was received for evaluation.Visual evaluation found no sign of crack on the jaws; however, it was noted that the jaw tip was bent, and show damage.No functional testing was performed due to the damage to the jaw tip.The reported condition is most likely caused by overstressing a device damaged naturally and inevitably due to normal wear or aging.

• Brand Name: SCORPION-MULTIFIRE, HUMPBACK
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18386075
• Report Number: 1220246-2023-09604
• Device Sequence Number: 11456326
• Product Code: LXH
• UDI-Device Identifier: 00888867015944
• UDI-Public: 00888867015944
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/05/2024

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: SCORPION-MULTIFIRE, HUMPBACK
• Device Catalogue Number: AR-13995
• Device Lot Number: 29289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown