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

Model Number	012044
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a meniscectomy surgery the punches busket is out of order, the mechanism is disassembled.The procedure was completed without significant delay using a competitor device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One straight duckling basket punch used for treatment, was returned for evaluation.The information provided states, ¿during a meniscectomy surgery the punches busket is out of order, the mechanism is disassembled¿.This is a one year old reusable instrument.The lower basket was in good condition.The lug was scratched and had a worn surface.The symptom aligns with being used in a grabbing or twisting action.Per instruction for use: ¿these instruments are designed for repeated use with proper care and handling.As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in the instrument¿s failure.Do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.¿ there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 10242117
• Report Number: 1219602-2020-00992
• Device Sequence Number: 2433254
• Product Code: NBH
• UDI-Device Identifier: 03596010023964
• UDI-Public: 03596010023964
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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: 012044
• Device Catalogue Number: 012044
• Device Lot Number: 50796657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention