MAUDE Adverse Event Report: ARTHREX, INC. FLEXIBLE TIGHTROPE® DRILL PIN; BIT, SURGICAL

Model Number	FLEXIBLE TIGHTROPE® DRILL PIN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
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
It was reported that during an anterior cruciate ligament surgery the tip of the device broke off and had to be removed from the joint.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-1298flx flexible tightrope® drill pin serial/batch number (b)(6) was received for investigation.Functional testing was not performed as the device was broken.Visual inspection revealed that the drill pin head had broken off.The entire shaft displayed scratches and damage.Discoloration was also noted, suggesting the possibility that the device may have been reused.Based on the device udi attributes information, the device is designated for single use.The most likely cause of the reported failure is worn and damage due to repeated use and/or reprocessing.

• Brand Name: FLEXIBLE TIGHTROPE® DRILL PIN
• Common Device Name: BIT, SURGICAL
• 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: jared engle ; 8009337001
• MDR Report Key: 19573567
• Report Number: 1220246-2024-06232
• Device Sequence Number: 15576533
• Product Code: HWE
• UDI-Device Identifier: 00888867274143
• UDI-Public: 00888867274143
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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
• Device Lot Number: 23D104
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown