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

Catalog Number 26-1221

Device Problem Material Discolored (1170)

Patient Problem No Information (3190)

Event Date 07/29/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When opening the package, the device was found discolored (like rust) at the tip of the blade despite brand new product.There were no adverse consequences associated with this event.

Manufacturer Narrative

Device was returned.A follow up will be filed upon completion of the investigation.

Manufacturer Narrative

Device evaluation: upon completion of the investigation, it was noted that the customer¿s complaint was verified.Some oxidation was observed on flutes drill body and inner drill.Root cause to the oxidation is unknown however, this most likely occurred out on the field.All perforators are visually inspected 100% during the in-process assembly.A review of the device history records (dhr) for this lot (bj023s) show that all test and inspections, including visual inspection, met specification requirements.The device history records (perforator assembly) shows that all tests and inspections, including visual inspection, met specification requirements.The customer's perforator met functional test acceptance requirements; proper engagement and disengagement was achieved with every drilled hole.There was no erratic or poor cutting action.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: 5864895
• MDR Text Key: 51846129
• Report Number: 1226348-2016-10568
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• 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: BJ0235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2016
• 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