MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REPAIR ARTHROPIERCE 45 DEG RIGHT; ACCESSORIES,ARTHROSCOPIC

Catalog Number 7209497R

Device Problem Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during the operation there was a rupture of metal on the working part of the device.Back-up device was available to complete the surgery.No patient injuries or significant delay reported.

Manufacturer Narrative

One 7209497 arthropierce 45 degree right configured device was used for treatment and returned for evaluation.This is a four year old reusable instrument.There is symptoms of twisting and torque noted.The actuator has been sprung.The nose has been twisted and fractured.This applies during use, washing and sterilizing.The instruments are subject to friction and entanglement with baskets, trays and other devices during sterilization loading and unloading.Inspection prior to use is required.If any damages are found, the device should be removed from use and returned promptly.There are no other complaints for this lot related to this observation.No root cause related to the manufacture of this device was determined.

Manufacturer Narrative

One 7209497 arthropierce 45 degree right configuration device used for treatment, was not returned for evaluation.This is a reusable instrument that had been previously refurbished.A photo was provided.It indicated that force/torque was a contributor to the condition of the device.It indicated that the articulating components have been damaged/broken.Product met specifications upon release to distribution.Complaint history review found other reports for this code.

• Brand Name: REPAIR ARTHROPIERCE 45 DEG RIGHT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8708677
• MDR Text Key: 148563776
• Report Number: 1219602-2019-00719
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2019

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: 7209497R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 07/09/2019; 08/26/2019
• Supplement Dates FDA Received: 07/10/2019; 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1