MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR 9MM; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number 26-1223

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Perforator did not release.The cranial perforator did not disengage.The surgeon could not reach the child cranium in order to begin the operative gesture.No consequences to the patient.Another like device was used.Per affiliate, no delays reported.

Manufacturer Narrative

Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.The cause(s) of the difficulty reported by the customer could not be determined.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.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.Device not available.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the customer's complaint was not verified.The customer's perforator met functional test acceptance requirements; proper engagement and disengagement was achieved with every drilled hole, and there was no erratic or poor cutting action.Device history records (perforator assembly) show all tests and inspections, including a drilling test on each perforator, met specification requirements.The device history records (dhr's) for this perforator (lot mh021s) were reviewed.All tests and inspections associated with the assembly, (including a 100% functional drill test and manual functional tests) met specification requirements.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.

Event Description

Perforator did not release.The cranial perforator did not disengage.The surgeon could not reach the child cranium in order to begin the operative gesture.No consequences to the patient - another like device was used.Per affiliate, no delays reported.

• Brand Name: CODMAN DISPOSABLE PERFORATOR 9MM
• 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: 6031768
• MDR Text Key: 57557867
• Report Number: 1226348-2016-10728
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1223
• Device Lot Number: MH021S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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