MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH BSKT SCP UPBTR 1.3MM; ACCESSORIES,ARTHROSCOPIC

Model Number 012030

Device Problems Flaked (1246); Difficult to Open or Close (2921)

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

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event 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.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.There was a relationship found between the device and 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.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 more loosely than designed with some instability.The duckbill 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.Consequently, we are unable to make any conclusions on the impact of the possibly retained non-implantable foreign body.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 confirmed, and the root cause was associated with unintended use of the device.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 SCP UPBTR 1.3MM
• 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: 15901916
• MDR Text Key: 304684996
• Report Number: 1219602-2022-01891
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010023551
• UDI-Public: 03596010023551
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

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
• Device Operator: Health Professional
• Device Model Number: 012030
• Device Catalogue Number: 012030
• Device Lot Number: L703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other