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

Catalog Number 26-1222

Device Problem Dull, Blunt (2407)

Patient Problem No Code Available (3191)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

The affiliate reported "the three mentioned experienced neurosurgeons tested the 11mm disposable codman perforator to compare them with their usual reusable perforator.The icp was set on 70000 rpm (as usual).A speed reducer was used as usual (golden color).It took a noticeably longer time to get through the bone than with their usual perforators.The perforator i'm sending in got very hot.They had to push really hard to make the perforator go through the bone.They also tried pushing less hard, but that made no difference.The craniotome they used to connect the three burr holes didn't struggle at all, so the neurosurgeon concluded that the skull wasn't particularly thick nor hard.They used the perforator in a 90 degree angle.The perforator wobbled in the fitting of the high speed drill.Please help explain why this perforator perforated so slowly, so i can communicate this back to customers.It would be great if you could let me know asap, since otherwise the current test might end unsuccessfully for codman.They use a midas rex high speed drill with "speed reducer" and icp system from medtronic we're testing the disposable perforators in this hospital at the moment (comparing them to reusables)".

Manufacturer Narrative

Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

It has been communicated that the device is not available for evaluation.Without the device it is not possible for codman to conduct a proper investigation.Since a lot number has been provided a review of the manufacturing records have been conducted and they revealed that the device conformed to all manufacturing and quality testing/inspection specifications prior to being released to stock.It has been noted that this is the second complaint reported for this product and lot number by the same customer.If at some point the device is returned for evaluation this complaint will be re-opened and investigated.Based on this evaluation 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: 3635292
• MDR Text Key: 20974769
• Report Number: 1226348-2014-11229
• 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: 02/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1222
• Device Lot Number: LF010S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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