MAUDE Adverse Event Report: ARTHREX, INC. 6X 20MM BC IF SCRW, VENTED; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number Ø6X 20MM BC IF SCRW, VENTED

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

Patient Problem Insufficient Information (4580)

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed.One unpackaged ar-4020c-06 was received for investigation.Visual inspection revealed that the ar-4020c-06 screw was returned in two fragments.It was identified using digital caliper id: 011 that one piece measured approximately 14.34mm in length, while the other was approximately 7.23mm in length.Heavy damage was present to the screw hex, impeding accurate measurements of the region.The driver used during the procedure was not returned for analysis.As such, the cause remains undetermined.

Event Description

It was reported that during an arthroscopy surgery the device didn`t fit on the screwdriver and broke inside the patient.No broken parts remained inside the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery time has been extended by approx.15 min due to the error and the surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.Update 09-jul-2021: it was confirmed that no part of the device broke off.No new bone tunnel had to be drilled and it was not necessary to widen the existing bone tunnel.Update, 02-sep-2021, received further information that the following screwdriver has been used: ar- 4019d fastthread¿ screw driver for 6 mm, batch.47321912.During returned device evaluation, a reportable malfunction was discovered.

• Brand Name: 6X 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
• MDR Report Key: 12576645
• MDR Text Key: 281079695
• Report Number: 1220246-2021-03747
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867276949
• UDI-Public: 00888867276949
• Combination Product (y/n): N
• PMA/PMN Number: K180662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Ø6X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-06
• Device Lot Number: 12597959
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/16/2021
• Patient Sequence Number: 1