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

Catalog Number	012044
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the case the unit broke into the patient and broken pieces were removed arthroscopically from the patient.There was a significant delay grater that 30 minutes.A backup device was available to complete the procedure with no patient injuries reported.
Additional Manufacturer Narrative
Hone duckling basket punch straight was returned for evaluation.Visual assessment of the device confirmed the reported complaint.The cutting basket (lower jaw) has been broken off and was not returned for evaluation.The break area is uneven in nature and shows no material voids.The device is over 11 years old and shows normal wear.The condition of the device indicates excessive forces were applied during use.Per the devices ifu under precautions ¿as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure¿.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.Complaint history search revealed no additional complaints for this production lot.

• Brand Name: PCH BSKT DCKLING STR
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8029005
• Report Number: 1219602-2018-01483
• Device Sequence Number: 16518661
• Product Code: NBH
• UDI-Device Identifier: 03596010023964
• UDI-Public: 03596010023964
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/15/2018

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 Catalogue Number: 012044
• Device Lot Number: 50228889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR