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

Model Number 371153-150

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/08/2022

Event Type  Injury  

Event Description

Aspen surgical received a report from a distributor indicating that a blade broke during a knee surgery.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 report from the distributor indicating that a blade broke during a knee surgery.The incident occurred at the end user.According the report, the surgeon was using the #15 blade when the end of it broke off inside the patient's knee.The surgeon was able to retrieve the broken part and confirmed all pieces were accounted for using visualization and x-ray.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.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 SAFETYLOCK 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: 14990921
• MDR Text Key: 295767135
• Report Number: 1836161-2022-00018
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 371153-150
• Device Lot Number: 0273390
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2022
• 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): Required Intervention; Other