MAUDE Adverse Event Report: ARTHREX, INC. SCREW, CANNULATED INTERFERENCE; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SCREW, CANNULATED INTERFERENCE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl surgery the thread of the screw did not grip in the drill channel.The product is therefore dislodged from the femoral drill channel.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the part number ar-1380.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-1370 cannulated interference screw, 7 x 20 mm batch 15235239 was received for evaluation.Visual inspection found scratches, nicks, and bents on the screw threaded body.Functional testing was not performed as not mating part or functional test equipment was available.However, the part was measurement to assure the dimensions were correct.Dimension "l".787 ±.005 results:.786.Major ø.275 ±.003 results:.275.Id ø.082 ±.002 results: pass.The most likely cause of the reported failure is user error, specifically improper bone preparation.

• Brand Name: SCREW, CANNULATED INTERFERENCE
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 21143552
• Report Number: 1220246-2025-09412
• Device Sequence Number: 9236845
• Product Code: MAI
• UDI-Device Identifier: 00888867014619
• UDI-Public: (01)00888867014619(11)240416(17)290331(10)15235239
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: SCREW, CANNULATED INTERFERENCE
• Device Catalogue Number: AR-1370
• Device Lot Number: 15235239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2024
• 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