MAUDE Adverse Event Report: ARTHREX, INC. STRAIGHT SPEAR, FM, FIBERTAK, REUSABLE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	STRAIGHT SPEAR, FM, FIBERTAK, REUSABLE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint is confirmed.Visual evaluation noted that the drill is stuck inside the driver ar-3610f, and the distal end of the flutes and the drill chuck feature were broken.Also, the distal end of the driver shaft has strong abrasion marks.Functional testing was not performed due to the devices being stuck and was not able to separate them.The most likely cause of this condition is excessive force/friction during use or insertion.
Event or Problem Description
It was reported that during a shoulder stabilization surgery the drill became stuck in the drill guide and broke off.All broken pieces were retrieved out of the patient.There was no harm for patient, operator or third party reported.As the hole was already drilled successfully no additional device was needed to finish the surgery successfully.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: STRAIGHT SPEAR, FM, FIBERTAK, REUSABLE
• 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: jared engle ; 8009337001
• MDR Report Key: 19360909
• Report Number: 1220246-2024-03599
• Device Sequence Number: 6341926
• Product Code: LXH
• UDI-Device Identifier: 00888867354272
• UDI-Public: 00888867354272
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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: STRAIGHT SPEAR, FM, FIBERTAK, REUSABLE
• Device Catalogue Number: AR-3610F
• Device Lot Number: 0072229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• 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