MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,4.5X 60MMCANN; BONE FIXATION PLATE

Model Number	LO-PRO SCRW,TI,4.5X 60MMCANN
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On 6/6/2023, it was reported by an arthrex employee via email ar-8945-60ft low profile screw produces debris upon insertion.The surgeon removed the screw and used another one to complete the case.This was discovered during a procedure on (b)(6)2023.Additional information requested.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.Since the complaint device was not returned, a physical evaluation of the device was not performed.However, without the device being returned or any photos provided, the reported event is not confirmed.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or excessive force being used during insertion of the screw.

• Brand Name: LO-PRO SCRW,TI,4.5X 60MMCANN
• 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: emily shafer ; 8009337001
• MDR Report Key: 17224028
• Report Number: 1220246-2023-07002
• Device Sequence Number: 7241655
• Product Code: HRS
• UDI-Device Identifier: 00888867053861
• UDI-Public: 00888867053861
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K141478
• 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): 06/10/2024

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 SCRW,TI,4.5X 60MMCANN
• Device Catalogue Number: AR-8945-60FT
• Device Lot Number: 13261432
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2021
• 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