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
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed that the first ar-1370c biocomposite interference screw broke off at the seventh thread prior to receipt for investigation, and the second screw broke at the fifth thread.The remaining distal ends of the screws were found to be twisted, which is consistent with breakage during insertion.Complainant's event is most likely caused by not inserting the implant co-axial to the bone tunnel, prying or leveraging, improper bone preparation or flexing the joint during insertion.Per product directions for use (dfu-0111), it is important to completely seat the screwdriver to prevent potential screw fracture during insertion.
Event or Problem Description
It was reported that during an acl procedure, the surgeon was attempting to insert a bio-composite interference screw, ar-1370c, and upon insertion, the screw broke leaving about 5mm of the screw in the pilot hole.A second bio-composite interference screw of the same lot was opened to be used.The surgeon tapped through the first broken screw fragment in an attempt to secure the fragment however, the second screw broke as well at the same length.5mm of the second screw was also left in the patient in the same pilot hole.The surgeon decided to create a second incision over the femur and inserted a button to secure fixation instead.

• Brand Name: BIO-COMP INTERFSCRW W/DISP SHTH
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8074663
• Report Number: 1220246-2018-00747
• Device Sequence Number: 244434
• Product Code: MAI
• UDI-Device Identifier: 00888867014633
• UDI-Public: 00888867014633
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: BIO-COMP INTERFSCRW W/DISP SHTH
• Device Catalogue Number: AR-1370C
• Device Lot Number: 10221249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/15/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other