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

Catalog Number 26-1221

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2012

Event Type  malfunction  

Event Description

Foreign matter like hair was found attached in the cap of the device before the package was opened.The product was not used for the patient.There were no adverse consequences to the patient.No delay in surgery greater than 30 minutes.(b)(4).

Manufacturer Narrative

(b)(4).Upon completion of the investigation, it was noted that the supplier performed this evaluation.Upon notification from the customer, (b)(4).Performed an audit of the room and reviewed the cap inventory to determine the potential source and did not find hair and/or particulate in the raw material stream.Reviewed the returned product once received with all personnel.(b)(4).Trends will be monitored for this and similar events.Based on the investigation this complaint is considered closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount dr.; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3799444
• MDR Text Key: 4473073
• Report Number: 1226348-2014-11537
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: LD007S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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