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

Catalog Number 26-1221

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

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2014

Event Type  malfunction  

Event Description

Affiliate reported that it was noted that rust like material was on the surface of the device.There were no adverse consequences to the patient.On 11/18/2014, additional information explained that the rust was found after opening the package during the first use.

Manufacturer Narrative

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

Manufacturer Narrative

Upon completion of the investigation it was noted that the visual evaluation revealed amber colored material on the surface of the metal (one location).This material could be easily scrapped from the metal surfaces indicating surface contamination.Once the contamination was removed there was no evidence of metallurgic defects such as corrosion.The root cause of this surface contaminates or identity of this material could not be verified.It is likely that manufacturing processes and/or customer handling processes introduced this contamination.This is the first complaint of this type for this product code and lot number.We will continue to monitor for this or similar complaints for this product code.At the present time this complaint is closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4270137
• MDR Text Key: 5298347
• Report Number: 1226348-2014-12109
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• 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: FG015S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2015
• 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