MAUDE Adverse Event Report: ASPEN SURGICAL BARD-PARKER; BLADE SURGICAL RIB BCK CARB 10

Model Number 371110

Device Problem Dull, Blunt (2407)

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

Event Type  malfunction  

Manufacturer Narrative

Samples of the aspen blades were sent by roi cps, llc to aspen surgical on 7/1/2020 after the initial complaints were received.Roi cps, llc requested that the manufacture of the blades perform an investigation and provide their corrective actions.

Event Description

Customer reported that every #10 blade with that lot number (0209336) was opened and compared with other blades was dull.The dull blades were contained within roi cps, llc custom pack (b)(4) open heart pack a&b and (b)(4) laminectomy pack.

Event Description

Customer reported that every #10 blade with that lot number (0209336) was opened and compared with other blades was dull.The dull blades were contained within roi cps, llc custom pack 800731001-open heart pack a&b and 800766003-laminectomy pack.

Manufacturer Narrative

Samples of the aspen blades were sent by roi cps, llc to aspen surgical on (b)(6) 2020 after the initial complaints were received.Roi cps, llc requested that the manufacture of the blades perform an investigation and provide their corrective actions.Roi cps, llc received a complaint closure letter from aspen surgical.I am attaching it to this report.

• Brand Name: BARD-PARKER
• Type of Device: BLADE SURGICAL RIB BCK CARB 10
• Manufacturer (Section D): ASPEN SURGICAL; 6945 south dr se; caledonia, mi
• MDR Report Key: 10465400
• MDR Text Key: 219190508
• Report Number: 3014527682-2020-00012
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371110
• Device Lot Number: 0209336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1