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

Model Number	012044
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the punch basket duckling was broken.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: the reported device, intended for use, in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed the set screw is missing.A functional inspection revealed the loop handle assembly could not activate the actuator.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.The complaint was confirmed and the root cause was associated with a component failure.Factors that could have contributed to the reported event include the application of excessive force resulting in instrument failure.

• Brand Name: PCH BSKT DCKLING STR
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10671964
• Report Number: 1219602-2020-01576
• Device Sequence Number: 2881671
• Product Code: NBH
• UDI-Device Identifier: 03596010023964
• UDI-Public: 03596010023964
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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 Model Number: 012044
• Device Catalogue Number: 012044
• Device Lot Number: 50759210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1