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

Model Number	BIO-INTERF SCRW
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/23/2018
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 expected but has not returned for evaluation.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 during an acl procedure, the screw broke when it was about 15mm into the tibial tunnel.Additional information provided 7/3/2018: not all the fragments were recovered.Part of the fragmented screw remained inside the patient.Distributor is trying to communicate with the patient in order to obtain x-rays.

• Brand Name: BIO-INTERF SCRW
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7713364
• Report Number: 1220246-2018-00563
• Device Sequence Number: 1120665
• Product Code: MAI
• UDI-Device Identifier: 00888867035478
• UDI-Public: 00888867035478
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K062466
• 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): 07/24/2018

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: 03/31/2020
• Device Model Number: BIO-INTERF SCRW
• Device Catalogue Number: AR-5035TB-10
• Device Lot Number: 10203651
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other