MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULATED OBTURATOR W/DELRIN 4.5MM; ACCESSORIES,ARTHROSCOPIC

Model Number 72200096

Device Problem Peeled/Delaminated (1454)

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

Event Date 04/21/2022

Event Type  malfunction  

Event Description

It was reported that during set up of a demo inventory, the black residue of the cannulated obturator was flaking causing a contamination.There was no patient involvement.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Internal complaint reference (b)(4).H10 h3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A complaint history review found no similar reported events.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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection of the returned device found that it is not in its original packaging.The markings on the device confirm the product identification information.The device is very worn from use, and the black color on the handle is severely faded.The material of the handle is cracked.The device is very corroded, and covered in abrasions.The distal opening of the shaft is deformed.The complaint was confirmed, and the root cause was associated with component failure.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, an impact event inconsistent with normal use, wear from prolonged use, misuse or rough handling, or inadequate routine maintenance.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: CANNULATED OBTURATOR W/DELRIN 4.5MM
• 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: 14399715
• MDR Text Key: 291714290
• Report Number: 1219602-2022-00703
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010542441
• UDI-Public: 03596010542441
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

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: 72200096
• Device Catalogue Number: 72200096
• Device Lot Number: 50320934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 06/14/2022
• Supplement Dates FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1