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 Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

Aspen surgical received a report from the end user of a bard-parker blade that broke during a procedure which was reported to the fda.The medwatch report for this incident was provided to aspen surgical.In this report, the end user indicated that a sample was available for evaluation and the manufacturing lot number was provided for review.During an arthroscopy shoulder surgery, a bard parker size 11 blade broke off in the soft tissue of the patient.The surgeon removed the broken blade in its entirety without incident.The patient tolerated well and follow up care was not required.Based on the evaluation conducted, lot 0075056 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 (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.Sample is pending return and evaluation.If any additional relevant information is identified following completion of the evaluation, the additional relevant information will be submitted in a supplemental report.

Event Description

Aspen surgical received a report from the customer indicating that a bard-parker blade broke off in patient during a procedure.The incident occurred at the user facility.Customer reported two lots (0075056 and 0129158) and was unsure which lot number the broken blade was associated with.Both numbers were filed for investigation.This report was filed in our complaint handling system as (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: 7297448
• MDR Text Key: 100976809
• Report Number: 1836161-2018-00023
• 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: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• 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: 0075056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2018
• 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: 19 YR
• Patient Weight: 36