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 04/11/2014

Event Type  malfunction  

Event Description

The affiliate reported "perforator was blunt, so they changed to a new one.Please note: since the event, the item has been washed by the hosptial before beeing sent in for investigation event date: unknown (will be same as awareness date in the form)".

Manufacturer Narrative

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

Manufacturer Narrative

Prior to sending the perforator to the supplier for evaluation, the perforator including the cutting edges was evaluated under high magnification (40x).There were no obvious anomalies noted on the cutting edges.The edges did not appear to be rolled, gouged or distorted.The label was torn, therefore; the lot number could not be confirmed.Root cause for the reported problem (perforator was blunt) was not verified.All evaluation tests and inspections had acceptable results.The perforator met functional test method acceptance requirements; proper engagement and disengagement was achieved with every drilled hole, there was no erratic and poor cutting action.A review of the device history records was not confirmed.The lot number is unknown; a section of eto label with lot# is torn away, and the lot# was not reported by the affiliate.Trends will be monitored for this and similar complaints.At the present time this complaint is considered 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: 3776026
• MDR Text Key: 4357228
• Report Number: 1226348-2014-11480
• 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: 26-1221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2014
• Initial Date FDA Received: 04/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2014
• 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