MAUDE Adverse Event Report: ARTHREX, INC. KREULOCK COMPRESSION SCREW, SS, 2.7X16MM; BONE FIXATION PLATE

Model Number	KREULOCK COMPRESSION SCREW, SS, 2.7X16MM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
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.One unpackaged ar-8827cl-16 batch number 14959488, was received for investigation.The visual evaluation found damage on the screw head hex and flute edges.Measurement of critical head and flutes dimensions cannot be taken because of the damage in the head hex and flutes edges.The most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.Refer to investigation photos #1-2.
Event or Problem Description
It was reported on 08/25/2022 by a sales representative via email that an ar-8827cl-16 kreulock screw would not screw into plate.This was discovered during a case with no patient harm.

• Brand Name: KREULOCK COMPRESSION SCREW, SS, 2.7X16MM
• Common Device Name: BONE FIXATION PLATE
• 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: 19487710
• Report Number: 1220246-2024-05304
• Device Sequence Number: 7024919
• Product Code: HRS
• UDI-Device Identifier: 00888867324206
• UDI-Public: 00888867324206
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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: KREULOCK COMPRESSION SCREW, SS, 2.7X16MM
• Device Catalogue Number: AR-8827CL-16
• Device Lot Number: 14959488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• 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