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 Information (3190)

Event Date 12/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon completion of the investigation, it was noted that the evaluation of the returned perforator revealed dark spots on the cutting area (metal surfaces, 3 locations).A visual inspection for particulate was performed.The particles on this perforator are smaller (or same size) as the test acceptable size requirements.The returned perforator was found to meet the packaging specifications.A review of the dhr revealed that this perforator met all testing requirements during manufacturing processes.This complaint is considered to be closed based on the particulates meeting specification.Based on the results of this investigation, no further action is required.Trends will be monitored for this and similar complaints.At the present time, this complaint is closed.

Event Description

Foreign substances were found inside the brand new package before use.There was no adverse consequence to the patient and no further information was provided by the hospital.

Manufacturer Narrative

Upon completion of the investigation it was noted that the evaluation of the returned perforator revealed staining on the cutting surfaces of the perforator.The exact root cause of the staining could not be verified; however, this staining is consistent in appearance with previous staining evaluated by the supplier.Previous evaluation of staining on returned perforators (found before use) is most likely associated with water residue attributed to the rinse process, this however could not be determined.The perforator for this complaint was manufactured prior to the changes implemented in july 2016.Dhr review was performed and revealed that this perforator meets all testing requirements during the manufacturing process.Further evaluation of the perforator for this complaint (perforator lot hj011s) is ongoing to address the affiliate's question regarding biocompatibility.If the evaluation reveals any additional information, this complaint will be reopened and a follow up will be filed.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.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.; new bedford industrial park; new bedford MA 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6260784
• MDR Text Key: 65098772
• Report Number: 1226348-2017-10055
• 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: 01/18/2017
• 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: HJ011S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• 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