MAUDE Adverse Event Report: ARTHREX, INC. LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical forces.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(4).
Event or Problem Description
On 6/1/2022 it was reported by a sales representative via email that a locking nut on the screw capturing rod snapped off.While trying to remove the screw, the locking mechanism was damaged.This was discovered during a hip fracture repair on (b)(6) 2022.Additional information received on 6/2/2022 over the phone: this was discovered during a hip fracture procedure and nothing broke inside the patient.Another tray was opened and case was completed without further issues.

• Brand Name: LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 19460563
• Report Number: 1220246-2024-04850
• Device Sequence Number: 18122114
• Product Code: HSB
• UDI-Device Identifier: 00848665036534
• UDI-Public: 00848665036534
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K202099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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: LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM
• Device Catalogue Number: 1192-090
• Device Lot Number: 212115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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