MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO LOCK SCRW,TI,3.5MMX 10MM; BONE FIXATION PLATE

Model Number	LO-PRO LOCK SCRW,TI,3.5MMX 10MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2024
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
On 07/19/2024, it was reported by a sales representative via sems- (b)(4) that an ar-8935l-10 low profile locking screw went straight through the ar-9943t-06 locking third tubular plate.This occurred during a procedure, the 3.5 locking screw went straight through the plate with little to no pressure like he wasn't cranking on the screw it just went straight through the plate, which isn't normal.They took everything out and replaced it with another ar-9943t-06 in the tray which had no issues and used a new ar-8935l-10 screw with no issues.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Upon visual inspection, it was noted that the screw did not have any issues.Dimensional testing was performed, and the device meets the requirement per drawing c21551.Functional testing was performed, and the device worked as required.No problem found.

• Brand Name: LO-PRO LOCK SCRW,TI,3.5MMX 10MM
• 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: 19920024
• Report Number: 1220246-2024-07055
• Device Sequence Number: 15258677
• Product Code: HRS
• UDI-Device Identifier: 00888867050839
• UDI-Public: 00888867050839
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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,3.5MMX 10MM
• Device Catalogue Number: AR-8935L-10
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/30/2024
• 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