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

Model Number 72201187

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a rotator cuff shoulder repair surgery, the cleverhook tip of a arthropierce instrument curved right became dislodged and subsequently embedded in tendon of patient.It was considered to left the tip inside of the joint because it could cause more harm to the patient if removed due to a possible need for tendon dissection.The procedure was completed with non-significant delay using a back-up device.No patient harms were reported.

Event Description

It was reported that during a rotator cuff shoulder repair surgery, the cleverhook tip of the arthropierce instrument became dislodged and subsequently embedded in tendon of patient.It was considered to leave the tip inside the joint because if the tip is removed it could cause further harm to the patient due to a possible need for tendon dissection.The procedure was completed with non-significant surgical delay using a back-up device.No patient complications were reported.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual inspection revealed two devices of the same lot number were returned outside of original packaging.One of the devices the distal jaw was broken from the device.The second device showed signs of use but no deformation visible.A functional evaluation revealed the first device with the fractured jaw could not be functioned as intended due to damaged tip.The second device would not function as intended as actuator could not open and close the distal jaw.A review of the customer provided image revealed the distal jaw of the device has become fractured.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The cleverhook tip of the arthropierce instrument is made of 17-4 ph stainless steel.The arthropierce instrument is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond the reported device breakage and retained foreign body could not be definitively determined.Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted at this time a review of the customer provided image revealed the distal tip of the device has become fractured.It was determined the device contributed to the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.

• Brand Name: ARTHROPIERCE INSTRUMENT CURVED RIGHT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12729416
• MDR Text Key: 279335675
• Report Number: 1219602-2021-02392
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010605627
• UDI-Public: 03596010605627
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201187
• Device Catalogue Number: 72201187
• Device Lot Number: 50591611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male