MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH BSKT DCKLING UPBTR; ACCESSORIES,ARTHROSCOPIC

Catalog Number 012045

Device Problem Failure to Cut (2587)

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

Event Date 07/19/2023

Event Type  malfunction  

Event Description

It was reported that, during a procedure, two (2) basket punch devices failed.The clamp of the first basket punch was not cutting correctly.The failure of the second basket punch reported is unknown.Surgery was completed after a significant delay (>30-minutes) using a back-up device instead.No further complications were reported.Patient's status is okay.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).D4, lot no: the following are the lot numbers reported: 51074715 and 51060928.However, it is unknown which of the two contributed with delay greater than 30 minutes.H4, mgf.Date: manufacturing dates for each of the 2 reported: 17-oct-2022 (51074715), 29-aug-2022 (51060928).

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 device shows wear from use, the laser engravings are present and legible but degraded.A functional evaluation of the device found it did cut cleanly through the test material.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.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.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: PCH BSKT DCKLING UPBTR
• 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: 17606769
• MDR Text Key: 321775892
• Report Number: 1219602-2023-01602
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010023995
• UDI-Public: 03596010023995
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/13/2023

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: 012045
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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