MAUDE Adverse Event Report: ARTHREX, INC. BIO-INTERFSCRW CAN-DELTATPRER 9X35MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-INTERFSCRW CAN-DELTATPRER 9X35MM
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Device disposition is unknown.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported, that on (b)(6) 2016 an ar-5035tb-09 bio- interference screw was placed in the tibia and 18 months the screw is removed without signs of biodegradation.Additional information obtained 7/13/2018: the patient's bone quality was reported to be medium.The original procedure took place on (b)(6) 2016.During the original surgery the ar-5035tb-09 bio-interference screw was implanted along with one ac tightrope rt.Nothing was implanted during the second surgery as the procedure was just to remove the ar-5035tb-09 bio-interference screw due to patient discomfort of placement of the same.
Additional Manufacturer Narrative
Complaint confirmed.The received screw was undamaged and did not show signs of biodegradation.Absorption of biodegradable implants begins at implantation as a result of normal hydrolysis of the implant.The rate at which the implant degrades and is reabsorbed can be affected by numerous factors including, but not limited to implantation site vascularity, stress on the implants, surgical techniques employed during implantation, patient factors (such as age, immune system status, bone quality, body chemistry and sensitivity to implant materials), and patient post-op compliance to rehabilitation protocols.There is no minimum or maximum established resorption rates for bioabsorbable implants.Bioabsorbable implants are designed with material properties required to maintain necessary properties throughout the healing process under normal patient conditions.

• Brand Name: BIO-INTERFSCRW CAN-DELTATPRER 9X35MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7713368
• Report Number: 1220246-2018-00564
• Device Sequence Number: 13707081
• Product Code: MAI
• UDI-Device Identifier: 00888867035461
• UDI-Public: 00888867035461
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: 12/31/2017
• Device Model Number: BIO-INTERFSCRW CAN-DELTATPRER 9X35MM
• Device Catalogue Number: AR-5035TB-09
• Device Lot Number: 10024303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/22/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other