MAUDE Adverse Event Report: ARTHREX, INC. LEFTY TIGHTY LAG SCREW, Ø10.5MM X 95MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	LEFTY TIGHTY LAG SCREW, Ø10.5MM X 95MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/2/2023, it was reported by a sales representative via email that the threads of an 1192-095 lefty tighty lag screw broke.While passing the nail, the threads of the lag screw broke and were retrieved successfully.The case was completed with another lag screw.This was discovered during a troch nail procedure on (b)(6) 2023.
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint was confirmed.One unpackaged 1192-095 serial/batch number (b)(6) was received for investigation.Visual evaluation found that the thread was broken/damaged.The reported condition is most likely caused by overstressing a device.When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.

• Brand Name: LEFTY TIGHTY LAG SCREW, Ø10.5MM X 95MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 17190321
• Report Number: 1220246-2023-06970
• Device Sequence Number: 14899285
• Product Code: HSB
• UDI-Device Identifier: 00848665036541
• UDI-Public: 00848665036541
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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 TIGHTY LAG SCREW, Ø10.5MM X 95MM
• Device Catalogue Number: 1192-095
• Device Lot Number: 230093
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• 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