MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BL CONCAVE EP-1 (BX 3); SAW, POWERED, AND ACCESSORIES

Catalog Number 7205335

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2021

Event Type  malfunction  

Event Description

It was reported that during set up or inspection in an acl, the newly purchased curved concave full radius was rusty.The clinician refuses to use them.There was a s+n back-up device available.Non-significant delay was reported, and no patient complications were reported.As per the preliminary results of the investigation, the inner shaft of device one has been fractured proximal to the curve.

Manufacturer Narrative

Internal complaint reference case-2021-00082181-1.

Manufacturer Narrative

Corrected data: further review of this case indicates this is a duplicate report.The event in this report has been already reported under mdr no.1219602-2023-02138.All further communication for this event will be managed in that case, including a follow up report with the results of our investigation.We respectfully request to close the case as a duplicate and refer to the referenced case above.

• Brand Name: FULL RADIUS BL CONCAVE EP-1 (BX 3)
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18079077
• MDR Text Key: 327737383
• Report Number: 1219602-2023-02159
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251626
• UDI-Public: 03596010251626
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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 Expiration Date: 12/05/2021
• Device Catalogue Number: 7205335
• Device Lot Number: 50809933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• 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