MAUDE Adverse Event Report: ARTHREX, INC. FW,BPB #2 SUTR,BLU W/NDL; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	FW,BPB #2 SUTR,BLU W/NDL
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/18/2020
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 during a procedure, three fiberwires, ar-7200, broke during the insertion of a bio-screw.All suture fragments were retrieved from the patient and discarded.The case was completed with no adverse effect to the patient.Additional information provided (b)(6) 2020: the broken end end of the final construct is implanted with the screws.Additional information provided (b)(6) 2020: there were a total of 3 sutures used consecutively and all 3 snapped at one end.For the first 2 sutures used, the surgeon removed them when they snapped but for the third suture, the surgeon left it implanted in the bone with the screws.

• Brand Name: FW,BPB #2 SUTR,BLU W/NDL
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10666727
• Report Number: 1220246-2020-02225
• Device Sequence Number: 11452478
• Product Code: GAT
• UDI-Device Identifier: 00888867041264
• UDI-Public: 00888867041264
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

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: 09/30/2024
• Device Model Number: FW,BPB #2 SUTR,BLU W/NDL
• Device Catalogue Number: AR-7200
• Device Lot Number: 21944
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/12/2020
• 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