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	01/25/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8349398
• Report Number: 1220246-2019-00907
• Device Sequence Number: 2138263
• Product Code: MAI
• UDI-Device Identifier: 00888867014633
• UDI-Public: 00888867014633
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 03/13/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other