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	02/05/2020
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 via fda medwatch letter (mw5092918) that while a patient was undergoing surgical repair of the left patella tendon, a needle tip being used broke off and lodged in the patient's patella tendon.The needle tip was left in place as removing it would have caused more harm than leaving it where it was.The fda medwatch letter did not contain any facility name or contact information.Therefore, at this time no further information is able to be obtained.

• 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: 9828871
• Report Number: 1220246-2020-01760
• Device Sequence Number: 19014372
• Product Code: GAT
• UDI-Device Identifier: 00888867041264
• UDI-Public: 00888867041264
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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 Model Number: FW,BPB #2 SUTR,BLU W/NDL
• Device Catalogue Number: AR-7200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other