MAUDE Adverse Event Report: ARTHREX, INC. TRIM-IT CANNULA INSERTION HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	TRIM-IT CANNULA INSERTION HANDLE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
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 during a hip labral repair surgery the handle of the device didn`t allow part ar-6590dt to slide down inside it.The obturator was not adjustable and as a result it was not usable to insert the trim it cannula.No part of the device broke.The surgeon had to insert the trim-it cannula by hand over a switching stick after making a larger capsulotomy.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.Update 17-jan-2022: it was confirmed that a larger incision had to be made in the capsule.
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 a hip labral repair surgery the handle of the device didn`t allow part ar-6590dt to slide down inside it.The obturator was not adjustable and as a result it was not usable to insert the trim it cannula.No part of the device broke.The surgeon had to insert the trim-it cannula by hand over a switching stick after making a larger capsulotomy.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.Update 17-jan-2022: it was confirmed that a larger incision had to be made in the capsule.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-6590dh handle and concomitant ar-6590dt were received for investigation.Functional testing identified that the obturator was unable to fully slide through the ar-6590dh handle.

• Brand Name: TRIM-IT CANNULA INSERTION HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 13393339
• Report Number: 1220246-2022-04340
• Device Sequence Number: 11825315
• Product Code: LXH
• UDI-Device Identifier: 00888867199583
• UDI-Public: 00888867199583
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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 Model Number: TRIM-IT CANNULA INSERTION HANDLE
• Device Catalogue Number: AR-6590DH
• Device Lot Number: 012031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown