MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE LOCKING SCREW 3.5 MM X 20 MM; BONE FIXATION SCREW/PLATE

Model Number	LOW PROFILE LOCKING SCREW 3.5 MM X 20 MM
Medical Device Problem Codes	Break (1069); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a lapidus surgery the screw did not fit properly into the plate.The surgery was finished successfully with a new device with the same part number.There was no harm for patient, operator or third party reported.It was not necessary to switch the surgical technique or do a second surgery.Update 02-feb-2024 dw: further information was provided that while the surgeon inserted the second screw it broke off.The broken piece was retrieved and the surgery was finished successfully with an additional screw with the same part number.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint is not confirmed.Visual inspection, no broken parts were observed on the screw.No problem found.Also, it was noted that the threads of the screw of the low-profile locking screw, titanium, 3.5 x 20 mm, sterile, im had stripped/damaged.Functional testing was not performed due to the damage to the device.

• Brand Name: LOW PROFILE LOCKING SCREW 3.5 MM X 20 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: 18710615
• Report Number: 1220246-2024-00983
• Device Sequence Number: 8201078
• Product Code: HWC
• UDI-Device Identifier: 00888867050921
• UDI-Public: 00888867050921
• 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,Followup
• Report Date (Section B): 08/21/2024

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: LOW PROFILE LOCKING SCREW 3.5 MM X 20 MM
• Device Catalogue Number: AR-8935L-20S
• Device Lot Number: 15131881
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• 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