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

Catalog Number	012045
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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).
Additional 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
• Common Device Name: 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
• Report Number: 1219602-2023-01602
• Device Sequence Number: 15029611
• Product Code: NBH
• UDI-Device Identifier: 03596010023995
• UDI-Public: 03596010023995
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 012045
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown