MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number 26-1221

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon completion of the investigation, a follow up report will be filed.

Event Description

It was reported that it could not be perforated at all.The product was replaced with another one (26-1221), and the surgery was completed.The product will be returned to your site.No patient harm or delay reported.

Manufacturer Narrative

(b)(4).The perforator was returned for evaluation.The device was visually inspected; no anomalies were found.The perforator was then tested for functionality.Five holes were drilled with the device per the test method.The device performed as intended.No issues identified.A review of manufacturing records found no anomalies during the manufacturing process.Based on the results of the investigation, the complaint could not be verified.The device functioned as intended.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; new bedford industrial park; new bedford MA 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6960883
• MDR Text Key: 90529010
• Report Number: 1226348-2017-10778
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 26-1221
• Device Lot Number: HC7370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2017
• 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