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

Catalog Number 012045

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the distal lower tip of the duckling upbiter broke.The broken part cannot be taken out and during the xray, it is seen in the posterior part of the articulation and due to the location, it is left in place.

Manufacturer Narrative

Examination is not possible, as the device has not been returned.Without the return of the device in question a root cause for this incident cannot be determined.A review of the device history records and quality records associated with this manufactured lot confirmed that no additional complaints have been filed and that no abnormalities were reported with this product lot during manufacture.The surgeon determined that the distal lower tip of the duckling upbiter that broke during a meniscectomy could not be removed due to its location.It is reported that the retained fragment was observed on x-ray to be in the posterior part of the articulation in the knee.There are no radiographs or medical documentation provided for review.The retained fragment is comprised of 17-4 stainless steel material.Based on astm and iso standards, the material composition would fall into a standardized medical grade alloy and, although not approved for implantation, standardized alloys have not been determined to cause injury or harm when the duration of contact with tissues/blood/bone is short-term, however, the fragment is not intended as an implantable device.The patient impact beyond the procedure cannot be determined as there is no report of the patient¿s current condition.Based on the limited information provided, no further clinical assessment is warranted.

• Brand Name: PCH BSKT DCKLING UPBTR
• 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
• MDR Report Key: 6744723
• MDR Text Key: 81070503
• Report Number: 1219602-2017-00817
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• 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: 09/19/2017

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: 012045
• Device Lot Number: 50136280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/26/2017
• Supplement Dates Manufacturer Received: 06/28/2017
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1