MAUDE Adverse Event Report: ARTHREX, INC. FLEXIBLE TIGHTROPE® DRILL PIN; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	FLEXIBLE TIGHTROPE® DRILL PIN
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via sems that an ar-1298flx flexible tightrope® drill pin had an issue.The pin tip broke off when the doctor began to use it.Patient was not affected or harmed and the case was completed successfully.This was discovered during use with no impact to the patient.On (b)(6) 2022, the sales representative provided the following information via email: this event occurred during an acl reconstruction procedure on (b)(6) 2022.The pin tip broke inside the patient, and all fragments were retrieved.The patient had normal bone quality, a new pin was provided and the case was completed with no impact to the patient.

• Brand Name: FLEXIBLE TIGHTROPE® DRILL PIN
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 14195783
• Report Number: 1220246-2022-04811
• Device Sequence Number: 12073504
• Product Code: HWE
• UDI-Device Identifier: 00888867274143
• UDI-Public: 00888867274143
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 04/25/2022

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 Model Number: FLEXIBLE TIGHTROPE® DRILL PIN
• Device Catalogue Number: AR-1298FLX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 04/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown