MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH BSKT DCKBL UPBTR 1.5MM; ACCESSORIES,ARTHROSCOPIC

Model Number	012014
Medical Device Problem Codes	Flaked (1246); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a knee scope, the punch failed to performed as expected.It is unknown if the device would not bite through tissue or it was difficult to open and close and was shedding metal.The procedure was completed with a s+n back up device.There was a non-significant surgical delay and no further complications were reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
H10: b5 and h6 upadted.
Event or Problem Description
It was reported that during a knee scope, the punch failed to performed as expected.It is unknown if the device would not bite through tissue or it was difficult to open and close and was shedding metal.The metal shaving were removed from the patient with a shaver blade.The procedure was completed with a s+n back up device.There was a non-significant surgical delay and no further complications were reported.The patient is fine.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A complaint history review found 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.The instructions for use was 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 visual inspection of the returned device found that it is not in its original packaging.The device has discoloration throughout the metal and there is some gouging of the metal on the shaft but there is no material missing.The cutting surface shows wear and damage from use but there is no material missing.A functional evaluation of the device found it did cut cleanly through the test material without resistance.The device articulates freely without resistance as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional clinically relevant medical information be provided, this case would be re-assessed.The complaint of difficult to open was not confirmed, and the root cause could not be determined.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.The complaint of flaked was not confirmed and the root cause could not be determined.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 DCKBL UPBTR 1.5MM
• 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: 15903498
• Report Number: 1219602-2022-01886
• Device Sequence Number: 6096531
• Product Code: NBH
• UDI-Device Identifier: 03596010023360
• UDI-Public: 03596010023360
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2023

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: 012014
• Device Catalogue Number: 012014
• Device Lot Number: 50952343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 12/07/2022; 01/30/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 12/12/2022; 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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
• Patient Sex: Unknown