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

Catalog Number 012044

Device Problems Component Missing (2306); Noise, Audible (3273)

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

Event Date 01/19/2019

Event Type  malfunction  

Event Description

It was reported that when dr.(b)(6) was performing acl surgery and he was going to use the duckling straight punch but when he opened and used for the procedure he heard a small creek sound at the end of the bite.The smooth bite of the punch was missing.A backup device was used to complete the surgery.

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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8312969
• MDR Text Key: 135507149
• Report Number: 1219602-2019-00152
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010023964
• UDI-Public: 03596010023964
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• 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: 50742185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1