MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. #11 BARD-PARKER CARBON STEEL SURGICAL BLADE

Lot Number 0050683

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 12/15/2017

Event Type  Injury  

Event Description

Pt admitted with right shoulder superior labral tear and right shoulder rotator cuff tendonitis / subacromial impingement.During surgery, the #11 surgical blade broke.The loose scalpel piece was able to be removed in its entirety from the subacromial region in an arthroscopic procedure.

• Brand Name: #11 BARD-PARKER CARBON STEEL SURGICAL BLADE
• Type of Device: #11 BARD-PARKER CARBON STEEL SURGICAL BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt drive se; caledonia MI 49316
• MDR Report Key: 7203004
• MDR Text Key: 97749392
• Report Number: MW5074657
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0050683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 70