MAUDE Adverse Event Report: ARTHREX, INC. PERC INSERT KIT FOR 3.0 MM KNOTLESS ST; MANUAL INSTR, GENERAL SURGICAL

Model Number	PERC INSERT KIT FOR 3.0 MM KNOTLESS ST
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2023 by a sales representative via email that an ar-1938pk perc insert kit had a drill bit that was jammed in the drill sleeve.This occurred on (b)(6) 2023 at an unspecified time without any case involvement.
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 device was not received for evaluation.Based off the information provided, the most likely cause is attributed to misuse due to interference with the mating instrument; however, due to the device not being returned, we are unable to confirm the reported event.

• Brand Name: PERC INSERT KIT FOR 3.0 MM KNOTLESS ST
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19558633
• Report Number: 1220246-2024-05925
• Device Sequence Number: 4812008
• Product Code: MDM
• UDI-Device Identifier: 00888867271647
• UDI-Public: 00888867271647
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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): 06/18/2024

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: PERC INSERT KIT FOR 3.0 MM KNOTLESS ST
• Device Catalogue Number: AR-1938PK
• Device Lot Number: 14968578
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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