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	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One duckling basket punch straight punch was returned for evaluation.Visual assessment of the device confirmed the reported complaint of breakage.The actuator has broken where it interfaces with the upper jaw.The upper jaw and broken portion of the actuator were not returned for examination.Dimensional assessment of the actuator confirmed an excessive amount of material has been removed from the actuator proximal to the break and no longer meets print specification.All operators within manufacturing work cell have been retrained to the specification for the assembly and inspection requirements for linear instruments.
Event or Problem Description
It was reported that during the surgery the tool shaft was offset.A backup device was available to complete the procedure with no delay or patient injuries.Additional information states that device broke down inside the patient, there were no separated parts (the mechanism was wedged).
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.

• 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: 8612006
• Report Number: 1219602-2019-00559
• Device Sequence Number: 16238537
• 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): 11/14/2019

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: 50706765
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1