MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFSCRW W/DISP SHTH; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number BIO-COMP INTERFSCRW W/DISP SHTH

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

Complaint confirmed.The tip of the implant is damaged and appears to be missing material.Several threads were found to be damaged on the outside.The most likely cause of failure is improper bone preparation, not inserting the implant co-axial to the bone tunnel and/or prying and leveraging the device.

Event Description

It was reported that during a bone-tendon-bone (btb) surgery when inserting the bio-comp interference screw into the femoral, the tip broke-off.The surgeon was not able to retrieve it, so it was left in the joint.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 29-jan-2019: the broken fragment is screwed tight in the joint.It cannot move.

Manufacturer Narrative

Complaint confirmed.The tip of the implant is damaged and appears to be missing material.Several threads were found to be damaged on the outside.The most likely cause of failure is improper bone preparation, not inserting the implant co-axial to the bone tunnel and/or prying and leveraging the device.

• Brand Name: BIO-COMP INTERFSCRW W/DISP SHTH
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8349398
• MDR Text Key: 136478779
• Report Number: 1220246-2019-00907
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867014633
• UDI-Public: 00888867014633
• Combination Product (y/n): N
• PMA/PMN Number: K071176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

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: 02/29/2020
• Device Model Number: BIO-COMP INTERFSCRW W/DISP SHTH
• Device Catalogue Number: AR-1370C
• Device Lot Number: 10200073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 03/13/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other