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

Catalog Number 26-1221

Device Problem Plunge (1462)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

Clinician was making a burr hole when the perforator plunged and became stuck in the patient¿s skull, eventually it was removed by drilling around the perforator.Clinician recorded this in the patient's notes, completed an incident form and was happy that the patient had not been harmed.

Manufacturer Narrative

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

Manufacturer Narrative

The perforator was sent to the supplier for evaluation; however, the supplier is unable to locate the device.It has been misplaced.Since the device has been misplaced it is not possible to conduct an investigation or a review of the device history records.It is very rare that devices are lost or misplaced.If and when the device has been located the complaint will be re-opened and investigated.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.Supplier misplaced the device sample.

Manufacturer Narrative

This complaint has been re-opened as the device was located.Upon completion of the investigation it was noted that functional testing on the returned perforator was not performed; the device pin was not received and the drill body has excessive damage (grinding marks cut into its surface).A review of the device history records show all tests and inspections, including a drilling test on each perforator, met specification requirements prior to distribution.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.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4255840
• MDR Text Key: 5045007
• Report Number: 1226348-2014-12102
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: FG003S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention