MAUDE Adverse Event Report: ARTHREX, INC. 5.5MM BC CORKSCREW FT W/ SUTURETAPE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	5.5MM BC CORKSCREW FT W/ SUTURETAPE
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/12/2019
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 distal portion of the device remains in the patient.The retrieved portion was reported to have been discarded.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 during a case, the surgeon piloted the patient's bone with an ar-1927pb.As he was inserting the implant, about halfway through, the ar-1927bct broke in half.The broken piece was retrieved from the patient but the distal portion stayed inside of the patient's bone.The case was completed with no further incident.

• Brand Name: 5.5MM BC CORKSCREW FT W/ SUTURETAPE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8390946
• Report Number: 1220246-2019-00943
• Device Sequence Number: 13811090
• Product Code: MAI
• UDI-Device Identifier: 00888867251267
• UDI-Public: 00888867251267
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082810
• 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
• Report Date (Section B): 03/05/2019

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: 08/31/2020
• Device Model Number: 5.5MM BC CORKSCREW FT W/ SUTURETAPE
• Device Catalogue Number: AR-1927BCT
• Device Lot Number: 10243018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/05/2019
• 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