MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLKC CLD 4.75X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-2324BCC

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/04/2016

Event Type  Injury  

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/is expected for evaluation but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.Lot number was not provided so device history record review cannot be performed.Complainant's event typically caused by improper bone preparation, not inserting the implant co-axial to the bone tunnel or prying/leveraging the driver while the implant is still loaded.The potential cause(s) of this event will be communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.Device expected but not yet returned.

Event Description

It was reported that when inserting, the bio-comp screw broke in the patient's patella.The performed procedure was an mpfl (medial patellofemoral ligament reconstruction).They tried to remove all pieces but some remained in the patient.Surgery was finished successfully.The rest of the bio-composite screw is fixed in the patella and the surgeon said there is no risk to the patient.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.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.Lot number was not provided, so device history record review cannot be performed.Complaint confirmed.The evaluation revealed that the bio-composite swivelock screw's distal tip is broken off.The device met all specifications as received.Complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel or improper bone preparation prior to insertion.The potential cause(s) of this event will be communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.

Event Description

It was reported that when inserting, the bio-comp screw broke in the patient's patella.The performed procedure was an mpfl (medial patellofemoral ligament reconstruction).They tried to remove all pieces but some remained in the patient.Surgery was finished successfully.The rest of the bio-composite screw is fixed in the patella and the surgeon said there is no risk to the patient.

• Brand Name: BIO-COMP SWVLKC CLD 4.75X19.1MM
• 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, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 5426774
• MDR Text Key: 38001369
• Report Number: 1220246-2016-00032
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-2324BCC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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