MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE XP BUTTRESS PLATE IMPLANT SYS; WASHER, BOLT NUT

Model Number	TIGHTROPE XP BUTTRESS PLATE IMPLANT SYS
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
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 the surgeon used a ar-8959tds bb tak and placed in the central hole of the buttress plate to keep the plate steady.After using fluoroscopy, the surgeon wanted to relocate the position of the plate and went to remove the bb tak.As the bb tak was being removed, the distal portion broke off and became embedded in the patient.The surgeon was able to use the cannulated drill bit from the set to pop the cortex and remove a small fragment of the bb tak; however, a small piece remained in the patient.

• Brand Name: TIGHTROPE XP BUTTRESS PLATE IMPLANT SYS
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11730902
• Report Number: 1220246-2021-02962
• Device Sequence Number: 14382975
• Product Code: HTN
• UDI-Device Identifier: 00888867352278
• UDI-Public: 00888867352278
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K201522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TIGHTROPE XP BUTTRESS PLATE IMPLANT SYS
• Device Catalogue Number: AR-8959TDS
• Device Lot Number: 12038643
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/27/2021
• Patient Sequence Number: 1