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

Model Number 371151-150

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that a bard-parker blade broke off in a patient during a procedure. In this report, it was noted that no lot number was available for evaluation. Photographic evidence was provided. During a procedure, the #11 bard-parker carbon rib-back blade broke into three pieces and became embedded in the tissue. The surgeon used an arthroscopic camera and graspers to successfully retrieve the three pieces without incident. The patient did not experience any adverse effects. The patient tolerated well and follow up care was not required. Due to no lot number being provided, an evaluation of the dhr records could not be performed. 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)(6) 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. Device not returned.

Event Description

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

• Brand Name: BARD-PARKER SAFETYLOCK 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: 7472237
• MDR Text Key: 106865873
• Report Number: 1836161-2018-00041
• 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

• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 371151-150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/05/2018
• 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 Treatment Data

Date Received: 04/30/2018 Patient Sequence Number: 1