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

Model Number 7209498

Device Problems Break (1069); Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case-(b)(4).The sample is under evaluation by the manufacturing site.

Event Description

It was reported that the arthropierce had a missing part.No case reported; therefore, there was no patient involvement.Preliminary results of investigation have concluded that device top jaw sheared off which makes it a reportable event.

Manufacturer Narrative

H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A complaint history review concluded this was a repeat issue.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 visual inspection found that the product information is faded and the top of the jaw is sheared off where it meets the actuator.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device tip, attempted correction of a damaged device, or an inadvertent impact event.No containment or corrective actions are recommended at this time.

• Brand Name: ARTHROPIERCE 45 DEGREE LEFT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12431236
• MDR Text Key: 270136553
• Report Number: 1219602-2021-01872
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010474537
• UDI-Public: 03596010474537
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

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 Model Number: 7209498
• Device Catalogue Number: 7209498
• Device Lot Number: T1605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 11/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1