MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE LOCKING SCREW 3.5 MM X 18 MM; BONE FIXATION SCREW/PLATE

Model Number	LOW PROFILE LOCKING SCREW 3.5 MM X 18 MM
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual inspection identified the screw threads of the low profile locking screw, titanium, 3.5 x 18 mm, sterile, im were stripped and peeled.The edges of the hexalobe hole had chipped.The anodized blue process had damage around the threads.The part was measured, and no findings were observed with the device returned.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.Per dfu-0125-11r0 -g precautions - 3.Use the appropriately sized drill bit for the screw.4.Damage to the driver or screw may result from failure to seat the driver fully into the screw or to align the driver properly with the screw.
Event or Problem Description
It was reported that during an arthroscopy the locking screw could not be tightened in the plate.The thread twisted and the screw was not usable.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: LOW PROFILE LOCKING SCREW 3.5 MM X 18 MM
• Common Device Name: BONE FIXATION SCREW/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: 20248994
• Report Number: 1220246-2024-07528
• Device Sequence Number: 7282028
• Product Code: HWC
• UDI-Device Identifier: 00888867050907
• UDI-Public: 00888867050907
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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: LOW PROFILE LOCKING SCREW 3.5 MM X 18 MM
• Device Catalogue Number: AR-8935L-18S
• Device Lot Number: 15053266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• 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