MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE 45 DEGREE LEFT; ACCESSORIES,ARTHROSCOPIC

Catalog Number 7209498

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Event Description

It was reported that during a shoulder arthroscopy, the arthropierce 45 forceps were passed over the tendon, they were forced and broken in the cavity.The material was completely removed and there were no traces left inside the cavity.The procedure was completed without delay using the same faulty device.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H10: internal complaint reference (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: ARTHROPIERCE 45 DEGREE LEFT
• 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: 18395852
• MDR Text Key: 331671420
• Report Number: 1219602-2023-02536
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010474537
• UDI-Public: 03596010474537
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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
• Device Catalogue Number: 7209498
• Device Lot Number: LT906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male