MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO LOCK SCRW,SS 2.7X 14MM; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO LOCK SCRW,SS 2.7X 14MM
Medical Device Problem Codes	Positioning Failure (1158); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported during the clavicle fracture plating surgery that the screw stripped when fixing it in the plate and the upper thread of the screw did not engage the plate.Per complaint reporter 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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-8827l-14 batch unk was received for evaluation.Visual inspection revealed that the hexalobe has damage due to mechanical stress or damage during use or handling.The device was evaluated according to the drawing specification.C1330 at revision 11, component c1330-03 at revision 9.Overall length: 0.551 ± 0.012 inches result: 0.553 inches head major thread diameter: 0.161 + 0.001/-0.000 inches, results: 0.162 inches head minor thread diameter: 0.139 + 0.001/-0.000 inches, results: 0.139 inches the most likely cause of the reported failure is user error, including excessive force and misalignment of the insertion.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-8827l-14 batch unk was received for evaluation.Visual inspection revealed that the hexalobe has damage due to mechanical stress or damage during use or handling.A functional test was performed using a well-known good plate (ar-2656dl), and it was observed that the screw sits properly in the plate's hole.The device was evaluated according to the drawing specification.C1330 at revision 11, component c1330-03 at revision 9.Overall length: 0.551 ± 0.012 inches result: 0.553 inches.Head major thread diameter: 0.161 + 0.001/-0.000 inches, results: 0.162 inches.Head minor thread diameter: 0.139 + 0.001/-0.000 inches, results: 0.139 inches.The most likely cause of the reported failure is user error, which may include improper bone preparation or misalignment during insertion.If the screw is not inserted at the correct angle, it will not sit properly in the plate¿s hole.

• Brand Name: LO-PRO LOCK SCRW,SS 2.7X 14MM
• 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: 22782368
• Report Number: 1220246-2025-03428
• Device Sequence Number: 18653315
• Product Code: HWC
• UDI-Device Identifier: 00888867047051
• UDI-Public: (01)00888867047051(10)NB
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Followup
• Report Date (Section B): 11/03/2025

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: LO-PRO LOCK SCRW,SS 2.7X 14MM
• Device Catalogue Number: AR-8827L-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 09/26/2025; 10/23/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/30/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown