MAUDE Adverse Event Report: CONMED LINVATEC BIOSCREW 8MMX20MM, BIOABSORBABLE INTERFERENCE SCREW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number C8017

Device Problems Break (1069); Difficult to Remove (1528); Device Slipped (1584); Malposition of Device (2616)

Patient Problems Rupture (2208); Foreign Body In Patient (2687)

Event Date 11/13/2013

Event Type  Injury  

Manufacturer Narrative

The returned pieces of the removal screw were evaluated by the quality engineer, who determined the pieces were from a 8mm bioscrew, bioabsorbable interference screw with the overall length of either a 20mm (item #c8017), 25mm (item #c8018) or a 30mm (c8019).A review of the installed base shipped records showed all three sizes have been supplied by the manufacturer to malaysia (where the original surgery was performed).Since only 2 broken pieces were returned, further evaluation to determine the exact length of the actual device was not possible.Based on the patient's age which was approximately (b)(6) years old at the time of the original surgery, the c8017 (20mm) was determined to be the most probable item used and was therefore selected for reporting this event.A review of the two-year complaint history for these products (01-jan-2012 - 26-jan-2014) shows no similar complaints from a total of (b)(4) products shipped.Based on available information, it is unclear whether the acl rupture was due to incorrect placement of the bioscrew during the original surgery in (b)(6) in (b)(6) 2012 or if post-operative care procedures were not properly followed by the teenage patient.To reduce the risk of patient injury, the ifu provides a number of contraindications, warnings and precautions.Insufficient quantity or quality of bone for attachment.Conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.Patients under the age of (b)(6) or those who have not reached skeletal maturity.Any decision to remove the device during a second procedure must take into consideration the potential risk to the patient of an additional surgical procedure.Implant removal must be followed by adequate postoperative management.Detailed instructions on the use and limitations of the device must be given to the patient.

Event Description

On (b)(6) 2013, the customer ordered the loan instruments from the international affiliate in (b)(4) for the removal of an "acl bioabsorbable screw".It was unclear at the time if this was a conmed linvatec screw.Surgery was performed on (b)(6) 2013.It was later learned that the patient was a young teenage female, who had a patella tendon acl repair in (b)(6) in (b)(6) 2012 and that the removal screw might be manufactured by conmed linvatec.Initial assessment by the surgeon indicated that the femoral screw was not in the right place (assumed to be due to the original surgery) and that the acl had ruptured, thus required a revision surgery to remove the screw.When the surgeon went in to remove the screw, it was found to be very loose and had broken in several places.It was further reported that the surgeon could not remove the last piece of the screw.He also elected to leave the tibial screw in place altogether.The torn acl and meniscus was cleaned up and the surgery was completed as intended.Information received from the user facility indicated that a new acl repair was not conducted and there was no plan to have the acl revised.No additional implants were used and no issues were noted during the explant surgery with respect to the instruments used.The two explanted pieces of the bioscrew removed from the patient were originally thought to have been discarded by the explanting facility, but were located in (b)(6) 2013 and returned to conmed linvatec for evaluation.A thorough evaluation of the pieces was found to be either from a 8mm diameter bioabsorbable interference screw 20mm (item #c8017), 25mm (item #c8018) or 30mm long (c8019).Since only 2 broken pieces were returned, further evaluation to determine the exact length of the actual device was not possible.Based on the patient¿s age which was approximately (b)(6) old at the time of the original surgery, the c8017 (20mm) was determined to be the most probable item used and was therefore selected for reporting this event.

• Brand Name: BIOSCREW 8MMX20MM, BIOABSORBABLE INTERFERENCE SCREW
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 3605868
• MDR Text Key: 18562826
• Report Number: 1017294-2014-00005
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C8017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR