MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO LOCK SCRW TI 4.5X16MM; BONE FIXATION PLATE

Model Number	LO-PRO LOCK SCRW TI 4.5X16MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
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 an osg arthrodese with ankle fusion plate system the screws produced debris.There was no harm for patient, operator or third party reported.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.Update dw 17-apr-2024: further information were provided that all fragments were retrieved out of the patient.
Additional Manufacturer Narrative
Additional information: b5.Update dw 01-jul-2024: further information was provided that the initially provided part numbers were incorrect.The customer complaint one ar-845l-46, one ar-8545l-34 and one ar-8545l-50.
Event or Problem Description
Update dw 01-jul-2024: further information was provided that the initially provided part numbers were incorrect.The customer complaint one ar-845l-46, one ar-8545l-34 and one ar-8545l-50.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-8545l-46 serial/batch number 14913751 was received for investigation.Visual inspection revealed that the screw has lost its anodized color, and the hexagonal geometry of the head is damaged.Additionally, the thread on the screw body diameter appears to be warped.The screw's overall length and outside diameter as per drawing c7252 at revision 8.Dimensional: overall length: 1.811±.012, 1003729 -caliper.Measurement.1.814.Dimensional: major thread diameter: ø.181+.000/-.005.1003783 micrometer.Measurement.: ø.177 functional testing was not performed as the device was received damaged.The most likely cause(s) for the reported failure can be a user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.Dfu-0125-eor4_fmt_en.E.Warnings.6.Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the device, are important considerations in the successful utilization of this device.The appropriate arthrex delivery system is required for proper implantation of the device.

• Brand Name: LO-PRO LOCK SCRW TI 4.5X16MM
• 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: 19238508
• Report Number: 1220246-2024-02757
• Device Sequence Number: 8048711
• Product Code: HRS
• UDI-Device Identifier: 00888867124875
• UDI-Public: 00888867124875
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K141735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2024

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: LO-PRO LOCK SCRW TI 4.5X16MM
• Device Catalogue Number: AR-8545L-16
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: Not provided; 08/22/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 07/23/2024; 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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