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 Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

Aspen surgical received a report indicating that a bard-parker blade detached while in use during a procedure.The incident occurred at the user facility.No manufacturing lot number or sample were provided for review.End user indicated that following a left shoulder arthroscopy, the surgical blade was retained in the patient's left shoulder for several days post discharge.The patient experienced post op discomfort and was evaluated in the emergency room and discharged.Several days later, patient was seen by the surgeon for post op visit where x-rays were obtained and noted the retained blade.The retained blade was surgically retrieved successfully.No further patient follow up required.Due to no manufacturing lot number provided, a review of the device history record could not be completed.The most probable root cause could be contributing to blade detached from handle condition where the handle could be damaged.However, this could not be verified due to no return in sample.Additionally, excessive force applied by the end user during surgery process could contribute to the condition.The following controls are in-place to mitigate blade detached from handle 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.No sample was available for return.Based on this information, no further action is required.

Event Description

Aspen surgical received a report from the distributor indicating that a bard-parker blade detached during a procedure.Incident occurred at the end user.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: 8633251
• MDR Text Key: 145838698
• Report Number: 1836161-2019-00040
• 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: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 371111-150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2019
• 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