MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULATED OBTURATOR W/DELRIN 5.0; ACCESSORIES,ARTHROSCOPIC

Model Number 72200097

Device Problem Sharp Edges (4013)

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

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during set-up (mdrd), it was noticed that a cannulated obturator had its tip damaged, its sharped.A non-significant delay was reported.No patient involvement.

Manufacturer Narrative

H2: additional information: d4 and h4.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The handle of the device is discolored and the shaft shows scratching and other signs of wear.The distal tip of the device is deformed and has some sharp edges from the deformation.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.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 was associated with unintended use of the device.Factors that could have contributed to the reported 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: CANNULATED OBTURATOR W/DELRIN 5.0
• 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: 15724996
• MDR Text Key: 303297444
• Report Number: 1219602-2022-01680
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

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 Model Number: 72200097
• Device Catalogue Number: 72200097
• Device Lot Number: 50377952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 12/06/2022; 12/26/2023
• Supplement Dates FDA Received: 12/08/2022; 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2011
• 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