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

Model Number	012045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that during an arthroscopy procedure, when the surgeon was using the basket punch, the bottom jaw broke off in the patient.Not all the pieces were removed from the patient, a broken piece has been left in the patient because the surgeon could not find a way to removed it.The procedure was completed with a delay greater than 30 minutes with a different surgical technique.No further complications were reported.
Event or Problem Description
It was reported that during a meniscectomy procedure, when the surgeon was using the basket punch, the bottom jaw broke off in the patient.The broken piece that broke off lodged near the popliteal tendon beneath the tibia and could not be retrieved.The procedure was completed with a delay greater than 30 minutes with a different surgical technique.The current patient status is fine.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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 no similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.A clinical review states the punch devices are manufactured and intended as externally communicating devices and are not approved for long-term internal tissue exposure and long-term implantation data is not available.The potential for micro-motion and/or migration, and local skin irritation/discomfort cannot be ruled out.Per case details, the procedure was reportedly completed using a different (unspecified type) surgical technique and a procedural delay greater than 30 minutes.No further complications reported and ¿the current patient status is fine.¿ therefore, no further clinical/medical assessment can be rendered at this time.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Internal complaint reference case-(b)(4).A1: patient identifier must be in blank.There is confirmation a patient was involved but there is no specific data of the patient.

• 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: 16616309
• Report Number: 1219602-2023-00419
• Device Sequence Number: 14735477
• Product Code: NBH
• UDI-Device Identifier: 03596010023995
• UDI-Public: 03596010023995
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 012045
• Device Catalogue Number: 012045
• Device Lot Number: L50039005
• 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: 03/02/2023
• Supplement Date Received by Manufacturer: 03/27/2023; 06/27/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 03/29/2023; 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2001
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown