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

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problem Injury (2348)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Per customer's report: patient in operating room for brain biopsy, during surgery the device cut thru the dura, clutch didn't stop when it should have, no damage to the brain.The top of the drill went in about 3 cm further than necessary.Patient needed ct scan to r/o bleeding.Ct showed no bleeding.

Manufacturer Narrative

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.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

Per customer: patient in operating room for brain biopsy, during surgery, the device cut thru the dura, clutch didn't stop when it should have, no damage to the brain.The top of the drill went in about 3 cm further than necessary.¿ did the reported event cause any delays in the procedure or surgery over 30 minutes? we do not think there was a 30 minute delay.What action was taken to resolve the issue? patient needed ct scan to rule out bleeding.Were there any adverse consequences to the patient? dura perforated, but no bleeding.

• 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: 6154189
• MDR Text Key: 61716707
• Report Number: 1226348-2016-10841
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 26-1221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention