MAUDE Adverse Event Report: ARTHREX, INC. BIO-COM INTERFERENCE SCREW, TAPERED TIP; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1360C

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/19/2015

Event Type  Injury  

Event Description

It was reported that during an acl reconstruction procedure, bone was extremely hard and it took twice as long to harvest the graft and get the bone plug out.Surgeon used an arthrotek tap to tap the femur prior to implanting screw.Surgeon was then driving the screw into the femur and the top of the screw broke.Surgeon removed the screwdriver and the top of the screw was still attached to the screwdriver.Sales rep had the nurse measure the broken top piece and it was determined that 18 mm of the screw was in the femur and 4 mm broke-off.Surgeon felt the screw was secure as is and nothing further was done to secure it.Top of the screw was discarded.Follow-up investigation: the screw was inserted until the last thread and the rounded proximal head snapped off which remained on the arthrotek tap.The screw squeaked a lot during insertion, and the surgeon felt the fixation was good.The patient had extremely hard bone.

Manufacturer Narrative

No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but part remains in the patient and cannot be returned therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.Complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel, prying or leveraging while still loaded, improper bone preparation or flexing the joint during insertion.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Part remained in patient.

• Brand Name: BIO-COM INTERFERENCE SCREW, TAPERED TIP
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4607503
• MDR Text Key: 19765831
• Report Number: 1220246-2015-00056
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2015

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: 05/01/2016
• Device Catalogue Number: AR-1360C
• Device Lot Number: 1188899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2015
• Initial Date FDA Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR