MAUDE Adverse Event Report: ARTHREX, INC. BIO-INTERF SCRW,FULL THD 7X 28MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number BIO-INTERF SCRW,FULL THD 7X 28MM

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The explanted screw piece was reported to have been discarded.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that an acl reconstruction was performed on (b)(6) 2017.On (b)(6) 2019 a revision surgery took place because half of the bio-interference screw was migrating out from the femur tunnel and got stuck into the medial ligament/ muscle structure.The half screw was retrieved.The acl was stable and in good function and that's why no further steps were necessary during this second surgery.

• Brand Name: BIO-INTERF SCRW,FULL THD 7X 28MM
• 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: 8735176
• MDR Text Key: 149232336
• Report Number: 1220246-2019-01174
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867014718
• UDI-Public: 00888867014718
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K062466
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: BIO-INTERF SCRW,FULL THD 7X 28MM
• Device Catalogue Number: AR-1370TB
• Device Lot Number: 10146473
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other