MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE; BARD-PARKER BLADE

Model Number 371111-150

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

The following controls are in-place to mitigate ¿broken blade¿ condition at aspen surgical (b)(4) site: heat treatment in-process at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.Heat treatment quality inspections at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.The 100% visual inspection by certified personnel is performed to segregate nonconforming material, including broken blades, prior to assembly and packaging process.Each associate performing 100% inspection process is certified and re-certified on an annual basis on blade defect criteria¿s.Capa (b)(4) was initiated to evaluate current controls in place corrective actions identified were completed and capa closed on 10/26/2015.Capa (b)(4) was also initiated to continue in the monitoring and improvement of current control.Device not available.

Event Description

During an arthroscopy procedure, item number 371111 broke during the surgical incision.

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE
• Type of Device: BARD-PARKER BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316
• MDR Report Key: 7231140
• MDR Text Key: 98679871
• Report Number: 1836161-2018-00007
• 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: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 371111-150
• Device Lot Number: 0127941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 116