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	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/12/2018
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 requested/is expected but has not returned for evaluation.The 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 a left acl procedure, the spade tip of the flexible tightrope® drill pin, ar-1298flx, broke off inside of the patient's femur as the surgeon was attempting to reverse the pin out of the bone to readjust position.The surgeon decided to leave the broken fragment in the femur and completed the tunnel with a flipcutter instead.The case was then completed with no further incident.

• 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
• MDR Report Key: 8132825
• Report Number: 1220246-2018-00787
• Device Sequence Number: 2261386
• Product Code: HWE
• UDI-Device Identifier: 00888867274143
• UDI-Public: 00888867274143
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

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: 04/30/2022
• Device Model Number: FLEXIBLE TIGHTROPE® DRILL PIN
• Device Catalogue Number: AR-1298FLX
• Device Lot Number: 17N43
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR