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	Foreign Body In Patient (2687)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/14/2022, it was reported by a sales representative via phone that a drill bit from anar-8929tds syndesmosis tightrope kit broke off and remains in patient.This was discovered during a syndesmosis tightrope procedure on (b)(6) 2022.Surgeon did not want to remove the broken piece because after surgery, patient will not be able to walk for 8 weeks and will reassess if need be after patient starts walking again.
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.If the device becomes available for evaluation, a follow-up report will be submitted.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13684340
• Report Number: 1220246-2022-04548
• Device Sequence Number: 11793446
• Product Code: HTN
• UDI-Device Identifier: 00888867352278
• UDI-Public: 00888867352278
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: TIGHTROPE XP BUTTRESS PLATE IMPLANT SYS
• Device Catalogue Number: AR-8959TDS
• Device Lot Number: 13860346
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/07/2022
• Date Device Manufactured: 08/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown