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 Foreign Body In Patient (2687)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

Aspen surgical received a notification letter from the fda indicating that medwatch report number mw5074502 was submitted from the end user of a bard-parker blade.In this report, the end user indicated that no sample was available for evaluation, only the manufacturing lot number was provided for review.During right shoulder surgery, a bard parker size 11 blade broke.The broken piece was located in the subacromial region.The surgeon removed the broken blade piece in its entirety without incident in an arthroscopic procedure.The patient tolerated well and follow up care was not required.Based on the evaluation conducted, lot 0050683 was packed per dhr and no non-conformance related to the broken blade were present.Packing process has established controls to mitigate broken blade condition, including a blade sensor that inspect 100% of packed pouches liner level prior to aluminum foil packaging.The following controls are in-place to mitigate ¿broken blade¿ condition at aspen surgical las piedras 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.Based on this information, no further action is required.

Event Description

Aspen surgical received a letter from the fda indicating that a customer submitted a medwatch report due to a bard-parker blade that broke off in patient during a procedure.The incident occurred at the user facility.This report was filed in our complaint handling system as complaint (b)(4).

• 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 ; 6165367508
• MDR Report Key: 7288905
• MDR Text Key: 100693410
• Report Number: 1836161-2018-00021
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• 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: 0050683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2014
• 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