MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE; SURGICAL BLADE

Model Number 371111-150

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Broken blade, no injury reported.

Manufacturer Narrative

The most probable root cause is the stamping or grinding process; however, the customer provided an incorrect lot date and was unable to return the sample for evaluation.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.100% visual inspection by certified personnel is performed to segregate nonconforming material, including broken blades, prior to assembly and packaging process.Each associate performing 100% inspection process is certified and re-certified on an annual basis on blade defect criterias.Capa (b)(4) was initiated to evaluate current controls in place corrective actions identified were completed and capa closed on 10/26/15.New capa (b)(4) was initiated for the broken blade defect.

Event Description

Broken blade, no injury reported.

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE
• Type of Device: SURGICAL BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: megan morrissey ; 6945 southbelt dr. s.e.; caledonia, MI 49316
• MDR Report Key: 6582153
• MDR Text Key: 75825393
• Report Number: 1836161-2017-00049
• 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,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371111-150
• Device Lot Number: 411035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2017
• 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