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 Code	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
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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 damage to both the head hexalobe and the body threads.The threads at the head appeared stripped.The observed damage is consistent with mechanical stress, likely incurred during use or handling.Further evaluation under magnification and micro-vu measurement identified a possible manufacturing defect¿some threads on the head were not fully formed.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.Results: 0.541 inches.Head major thread diameter: 0.161 + 0.001/-0.000.Inches, results: 0.157 inches head minor thread diameter: 0.139 + 0.001/-0.000.Inches, results: 0.141 inches the most likely cause of the reported failure is a manufacturing issue.However, since the batch number is unknown, no further action can be taken.
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 damage to both the head hexalobe and the body threads.The threads at the head appeared stripped.The observed damage is consistent with mechanical stress, likely incurred 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 in the plate's hole.However, when the screw is moved using the threaded portion of the body, it disengages easily, which could potentially affect proper plate placement.Further evaluation under magnification and micro-vu measurement identified a possible manufacturing defect¿some threads on the head were not fully formed.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.Results: 0.541 inches.Head major thread diameter: 0.161 + 0.001/-0.000.Inches, results: 0.157 inches.Head minor thread diameter: 0.139 + 0.001/-0.000.Inches, results: 0.141 inches.The most likely cause of the reported failure is a manufacturing issue, as the head threads appear to be missing or not properly formed.However, since the batch number is missing, further investigation cannot be completed.Without this information, no further action can be taken.

• 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: 22782703
• Report Number: 1220246-2025-03432
• Device Sequence Number: 8236697
• 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: 10/01/2025; 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