MAUDE Adverse Event Report: ARTHREX, INC. DISP INSTR. KIT FOR SM JNT S-TAK; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DISP INSTR. KIT FOR SM JNT S-TAK
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
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.The complaint cannot be confirmed without the return of the device for evaluation.The failed device was not received for evaluation, and no pictures or videos of the failure were provided.Per the event description, it is concluded that the instrument was bent.The most likely cause(s) of the reported failure are user error, improper bone preparation, or misaligned insertion.
Event or Problem Description
On 05/19/2023, it was reported by a sales representative via (b)(4) that a faulty drill bit (ar-8934dcs lot- 14958587 bent drill) was used on 5/18/23 at 7:20 am at st.Joseph's hospital in chippewa falls, wi with dr.(b)(6) while performing a brostrom repair.Patient was not affected.

• Brand Name: DISP INSTR. KIT FOR SM JNT S-TAK
• 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: 19505277
• Report Number: 1220246-2024-05483
• Device Sequence Number: 20566063
• Product Code: LXH
• UDI-Device Identifier: 00888867050396
• UDI-Public: 00888867050396
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 06/10/2024

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: DISP INSTR. KIT FOR SM JNT S-TAK
• Device Catalogue Number: AR-8934DSC
• Device Lot Number: 14958587
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown