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

Catalog Number 7209497

Device Problem Break (1069)

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference number: (b)(4).

Event Description

It was reported that during set up for an arthroscopy, the arthropierce 45° right was found detached in the middle.In addition, a part of the jaw broke off.There was no surgical delay reported.There was no patient involvement.

Manufacturer Narrative

H10: internal complaint reference (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an evaluation of the customer provided images were performed and found the device was broken in half.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, 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.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the failure include rough handling or excessive force to the device no containment or corrective actions are recommended at this time.

• Brand Name: ARTHROPIERCE 45 DEG 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: 18695437
• MDR Text Key: 335253164
• Report Number: 1219602-2024-00274
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010474520
• UDI-Public: 03596010474520
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: Followup
• Report Date: 04/17/2024

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: 7209497
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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