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	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/07/2020
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 an orthopedic procedure a portion of the tip on the ar-7200 fiberwire # 2 braided polyblend suture w/ tapered needle broke off inside the patient (approx.2mm).The facility reported x-ray and c-arm confirmed the foreign subject to be in the patient's knee (not affecting the joint or ligaments).Additional information has been requested.Additional information received on 02/11/2020: the facility reported the procedure taking place was a primary patellar tendon repair.There was not an arthrex sales representative present during the case.The tip of the device broke off during the actual tendon repair.The knee was flushed, and a flat plate x-ray of the knee done and c-arm was used to locate the tip.After determining the location, no further attempt was made to retrieve the broken tip.The facility reported the surgeon does not plan to perform a second surgery.The complaint device (minus the un-retrieved broken tip) will be returning for evaluation.
Additional Manufacturer Narrative
Complaint confirmed, the tip of the needle was found to be broken.A most likely cause for this type of event would be the use of excessive force to pass the needle through thick or hard tissue or hitting bone with the needle.There is a label on the device warning the user against re-sterilizing, reusing, hitting bone or use of excessive force as these may result in needle breakage or patient injury.

• 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: 9756011
• Report Number: 1220246-2020-01721
• Device Sequence Number: 11460031
• Product Code: GAT
• UDI-Device Identifier: 00888867041264
• UDI-Public: 00888867041264
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2020

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: 03/31/2024
• Device Model Number: FW,BPB #2 SUTR,BLU W/NDL
• Device Catalogue Number: AR-7200
• Device Lot Number: 21117
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other