MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE INSTRUMENT CURVED LEFT; ACCESSORIES,ARTHROSCOPIC

Model Number 72201186

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/29/2020

Event Type  Injury  

Event Description

It was reported that during a shoulder arthroscopy, the tip of the arthropierce instrument curved left broke when it was being passed through the tissue.The broken tip was removed from the patient.The procedure was successfully completed without significant delay using a arthropierce instrument curved right.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that during a shoulder arthroscopy, the tip of the arthropierce instrument curved left broke when it was being passed through the tissue.The broken tip was removed from the patient with a grasper.The procedure was successfully completed without significant delay using a arthropierce instrument curved right.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.The customer provided image confirms the product identification information and that the tip of the device has been fractured.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found: o as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure o excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips the complaint was confirmed.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include force inconsistent with normal use.

• Brand Name: ARTHROPIERCE INSTRUMENT CURVED LEFT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10726923
• MDR Text Key: 212737668
• Report Number: 1219602-2020-01643
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010605610
• UDI-Public: 03596010605610
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201186
• Device Catalogue Number: 72201186
• Device Lot Number: 50584644
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 10/21/2020; 01/21/2021
• Supplement Dates FDA Received: 10/28/2020; 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention