MAUDE Adverse Event Report: ASPEN SURGICAL BARD-PARKER; BLADE SURG RIB BCK CARB 11

Model Number 371111

Device Problems Break (1069); Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  malfunction  

Event Description

11 blade snapped in half during case.Discovered during case.There was patient contact; however, no harm to patient and no delay to case.The dull blades were contained within roi cps, llc custom pack 880096033-nuero pack lot 79925ag.

• Brand Name: BARD-PARKER
• Type of Device: BLADE SURG RIB BCK CARB 11
• Manufacturer (Section D): ASPEN SURGICAL; 6945 southbelt dr; caledonia MI 49316
• Manufacturer (Section G): ASPEN SURGICAL; 6945 southbelt dr; caledonia MI 49316
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4177303937
• MDR Report Key: 10658785
• MDR Text Key: 212794138
• Report Number: 3014527682-2020-00018
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371111
• Device Lot Number: 0202069, 0212476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2020
• 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