MAUDE Adverse Event Report: ARTHREX, INC. Ø7X 30MM BC IF SCRW, VENTED; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number Ø7X 30MM BC IF SCRW, VENTED

Device Problems Break (1069); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2023

Event Type  malfunction  

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 Description

It was reported that during an anterior cruciate ligament surgery the screw fractured while being inserted.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update avoe (b)(6) 2023.It was confirmed that no broken parts remained inside the patient.

Manufacturer Narrative

The complaint was confirmed.One unpackaged ar-4030c-07 serial/batch (b)(6) was returned for investigation.The returned interference bio screw was visually inspected and noted that it was broken.Damage was observed inside the screw.The inside geometry was lost.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause is continually applying torque when the implant is seated and /or not advancing.Per dfu-0111 at revision 1.G.Precautions.6.Bio-absorbable interference screw only: it is important to completely seat the screwdriver to prevent potential stripping of the hex and/or screw fracture during insertion or removal.

• Brand Name: Ø7X 30MM BC IF SCRW, VENTED
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 17445925
• MDR Text Key: 320385638
• Report Number: 1220246-2023-07393
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867277649
• UDI-Public: 00888867277649
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K180662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Ø7X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-07
• Device Lot Number: 15003347
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1