MAUDE Adverse Event Report: ARTHREX, INC. T-FIX II DRL PIN & GRAFT PASS WIRE SET; BIT, DRILL

Model Number	T-FIX II DRL PIN & GRAFT PASS WIRE SET
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
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
It was reported that the device broke during a surgery.There was no harm for patient, operator or third party reported.No further information received.Update 29-sep-2022: it was confirmed that the error occurred during an anterior cruciate ligament surgery on the (b)(6) 2022.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
Complaint confirmed.One unpackaged ar-1978s-1 serial/batch number (b)(4) was received for investigation.Only the graft passing wire was returned for examination.Visual evaluation of the graft passing wire found that the strand braided nitinol wire is broken.The root cause of the reported failure mode is undetermined.However, the most probable cause is applying excessive mechanical forces upon insertion/use.

• Brand Name: T-FIX II DRL PIN & GRAFT PASS WIRE SET
• Common Device Name: BIT, DRILL
• 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: 15614995
• Report Number: 1220246-2022-05617
• Device Sequence Number: 12211819
• Product Code: HTW
• UDI-Device Identifier: 00888867025189
• UDI-Public: 00888867025189
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: T-FIX II DRL PIN & GRAFT PASS WIRE SET
• Device Catalogue Number: AR-1978S-1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown