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)" on (b)(6) 2014 affiliate asked to clarify quantity 3 each - were there 3 different patients involved? on (b)(6) 2014 affiliate responded - yes, 3 different patients/complaints - see also (b)(4) and (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Upon completion of the investigation, it was noted that the returned perforator was visually inspected as received, disassembled and cleaned, and then visually and dimensionally inspected.Visual examination of the drill driver revealed a damaged groove.The perforator was reassembled and functionally tested for cutting and drilling.It was found to meet specification requirements.The reported condition could not be duplicated.Review of the device history record has found no discrepancies.Trends will be monitored for this and similar complaints.At this time, the complaint is considered to be 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: 3635268
• MDR Text Key: 3988694
• Report Number: 1226348-2014-11228
• 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

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2014
• Initial Date FDA Received: 02/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2013
• 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