MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE; BARD-PARKER BLADE

Model Number 371115-150

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/05/2022

Event Type  Injury  

Event Description

Aspen surgical received a medwatch notification from the fda indicating that a blade broke during a diskectomy of the l4-l5 vertebral body.The scalpel was used to scrape bony defects during the decompression procedure.During this process the tip of scalpel broke to the right side of the l4-l5 disc space.The incident occurred at the end user.The issue was filed in our complaint handling system under number (b)(4).

Manufacturer Narrative

Aspen surgical received a medwatch notification from the fda indicating that a blade broke during a diskectomy of the l4-l5 vertebral body.The incident occurred at the end user.According the report, the scalpel was used to scrape bony defects during the decompression procedure.During this process the tip of scalpel broke to the right side of the l4-l5 disc space.Additional information was received from the end user indicating that before the break, decompression of the nerve root and thecal sac was accomplished.Then during the discectomy there was a small break in a knife blade with approximately 2 to 3 mm of blade deep in the vertebral body.After the break, attempt was made to remove, but realized to remove it would have require a takedown of the vertebral body and given the location and the size, the decision was made to leave this in place.A review of the device history record was completed.No non-conformance's were noted during the device history record review.The most probable root cause could have been during the stamping or grinding process.Packaging process has established controls to mitigate broken or cracked blade condition, including a "medio" blade sensor that inspects 100% of packed pouches liner level prior to aluminum foil packaging.Also, excessive force applied by end user during surgery process could also cause blade condition.Additionally, according to the instructions for use, the blade is specifically intended "for tissue separation and other procedures that require a sharp surgical blade to puncture or cut." as indicated in the initial end user report, the blade was utilized to "scrape bony defects" which is not part of the intended use of the device, which potentially attributed to the cause of the breakage.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 additional actions required.Device not returned.

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, 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: 14577529
• MDR Text Key: 293195813
• Report Number: 1836161-2022-00014
• 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 Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 371115-150
• Device Lot Number: 0256657
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2022
• 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