MAUDE Adverse Event Report: ARTHREX, INC. BIO-INTERFERENCE SCREW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-INTERFERENCE SCREW
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/06/2019
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.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the arthrex bio-interference screw ar-5028b-08 was used during an acl surgery.During insertion the screw broke inside the patient.The broken fragments had to be removed piece by piece.There are still fragments remaining inside the patient.The retrieved fragments were discarded after surgery and cannot be returned for evaluation.The surgery was completed successfully.No further information received.

• Brand Name: BIO-INTERFERENCE SCREW
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9568969
• Report Number: 1220246-2020-01553
• Device Sequence Number: 374567
• Product Code: MAI
• UDI-Device Identifier: 00888867035287
• UDI-Public: 00888867035287
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/09/2020

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: 08/31/2021
• Device Model Number: BIO-INTERFERENCE SCREW
• Device Catalogue Number: AR-5028B-08
• Device Lot Number: 10376653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other