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

Catalog Number 26-1221

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 06/24/2013

Event Type  malfunction  

Event Description

The affiliate reported that the perforator is not drilling through the corkcalis.The drill stayed in spongiosan.When drilling hole, 2 (drieat) it almost did not drill through the bone.A midas rex electric drill med ipc console was used.The rep reported that there were no adverse consequences.No delay was reported.

Manufacturer Narrative

Per the new matrix on 12/06/2013, this file is being reported as a malfunction.The returned perforator was visually inspected as received, disassembled and cleaned, and then visually and dimensionally inspected.No discrepancies were found.The perforator was reassembled and was functionally tested for cutting and drilling.The perforator did not have poor cutting action.The reported condition could not be duplicated.All evaluation tests and inspections had acceptable results.The perforator's failure to disengage is most likely related to the pitting and corrosion damage observed on the drive pin and the drill body.This damage is comparative to that which would be seen if the perforator was exposed to an extended soak in a cold sterilization solution.This issue (pitting and corrosion) is not related to the subject complaint reported by the customer.Review of the device history record has found no discrepancies.The complaint cannot be confirmed.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: 3551735
• MDR Text Key: 4211539
• Report Number: 1226348-2014-10153
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• 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: DF0165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2013
• 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