MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTER-FERENCE SCRW; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number BIO-COMP INTER-FERENCE SCRW

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

Patient Problem Foreign Body In Patient (2687)

Event Date 06/09/2021

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 reconstruction surgery the devices didn`t fit in the screwdriver.After the screwdriver was forced into the devices it was not possible to implant the devices properly in the tibial tunnel.The devices broke inside the patient and a clamp was used to secure the implant in place.The broken parts remained inside the patient.According to the surgeon no harm for patient, operator or third party occurred.It was not necessary to do a second surgery.

• Brand Name: BIO-COMP INTER-FERENCE SCRW
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, 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: 12076258
• MDR Text Key: 261463001
• Report Number: 1220246-2021-03341
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867035331
• UDI-Public: 00888867035331
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: K071176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: BIO-COMP INTER-FERENCE SCRW
• Device Catalogue Number: AR-5028C-09
• Device Lot Number: 10940892
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2021
• Date Device Manufactured: 05/08/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1