MAUDE Adverse Event Report: ARTHREX, INC. TELESCOPING LAG SCREW, LT, 10.5 X 100MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	TELESCOPING LAG SCREW, LT, 10.5 X 100MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	04/22/2024
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
On 04/24/2024, it was reported by a sales representative via e-mail that an ar-9094-100l telescoping lag screw broke.This occurred during a case.No additional information was provided, and additional information has been asked.Additional information received on 4/26/2024: this was discovered during a hip fx intertroch fx procedure.Upon insertion of the ar-9094-100l telescoping lag screw, it broke.The fragments were not removed.The case was completed using a 100mm galileo lag screw, right threaded.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-9094-100l batch 15111961 was received for investigation.Functional testing doesn't apply to this device.Visual inspection revealed that the screw thread had become detached and was bent.The most likely cause(s) of the reported failure are user error, misaligned insertion, or excessive force during use.

• Brand Name: TELESCOPING LAG SCREW, LT, 10.5 X 100MM
• 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: 19380009
• Report Number: 1220246-2024-03691
• Device Sequence Number: 20755356
• Product Code: HSB
• UDI-Device Identifier: 00888867410046
• UDI-Public: 00888867410046
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K230257
• 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): 09/16/2024

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: TELESCOPING LAG SCREW, LT, 10.5 X 100MM
• Device Catalogue Number: AR-9094-100L
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 08/31/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 09/16/2024
• 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