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

Catalog Number 012044

Device Problems Loss of Power (1475); Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2019

Event Type  malfunction  

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 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).

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
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8612006
• MDR Text Key: 145353369
• Report Number: 1219602-2019-00559
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010023964
• UDI-Public: 03596010023964
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 11/11/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1