MAUDE Adverse Event Report: ARTHREX, INC. Ø7X 20MM BC IF SCRW, VENTED; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number Ø7X 20MM BC IF SCRW, VENTED

Device Problems Break (1069); Fitting Problem (2183)

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

Event Date 04/12/2022

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 a posterolateral corner reconstruction surgery the screw was not fitting on the screw driver properly which lead to breaking the screw during insertion.The broken piece was retrieved from patient.Then they opened another one same screw size but different lot number the same problem happened.The screw is not fitting on the screw driver and then opened a third one, it fit correctly and was used without any problems.There was no harm for patient, operator or third party.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.

• Brand Name: Ø7X 20MM 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: vik bajnath ; 8009337001
• MDR Report Key: 14269880
• MDR Text Key: 299484531
• Report Number: 1220246-2022-04825
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867276956
• UDI-Public: 00888867276956
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: Ø7X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-07
• Device Lot Number: 10785010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1