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

Device Problems Break (1069); Defective Device (2588)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2023

Event Type  malfunction  

Event Description

It was reported that the flip did not release.There was no harm for patient, operator or third-party.Update 25-jan-2023: the incident occured during an anterior cruciate ligament surgery on (b)(6) 2023.The defective flipcutter broke off inside the joint.The individual parts of the defective item had to be collected piece by piece from the knee.There was no harm for patient, operator or third party.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.

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.

Manufacturer Narrative

Complaint is confirmed.Upon visual investigation, it was noted that the cutter tip and cutter pins were detached from the device, and the two slots at the distal end of the shaft were bent.The broken pieces were not returned for investigation.The wave spring and button were damaged.The probable cause of this condition is excessive force/friction during use or insertion.Additionally, it was also noted that the plastic component of the device was discolored.The most likely cause for discoloration is attributed to a cleaning process either at the customer or during returned device decontamination at arthrex.Functional testing was not performed due to the damage to the device.

• Brand Name: UNK
• Type of Device: 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: 16361848
• MDR Text Key: 309656409
• Report Number: 1220246-2023-06284
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1