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

Catalog Number 26-1230

Device Problem Failure to Auto Stop (2938)

Patient Problems Tissue Damage (2104); Brain Injury (2219)

Event Date 08/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain additional information.Upon receipt of new relevant information, a follow-up report will be submitted.

Event Description

As reported by the affiliate, a perforator being used with a medtronic drill did not disengage, causing damage to the patient's dura.Another was used to complete the procedure.

Manufacturer Narrative

Udi -- (b)(4).It was initially reported that the device would be returned for evaluation.However, it was later communicated that the device would not be returned.The previously reported lot number has also been corrected.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released to stock.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

Manufacturer Narrative

It was previously reported that the device was not returned.The device has been returned and is awaiting evaluation.This report has been updated to reflect the corrected information.

Manufacturer Narrative

Udi: (b)(4).The device was returned for evaluation.The perforator was visually inspected.The label was slightly worn, no other anomalies observed.Functional testing was then performed.A series of holes were drilled per the test method without issue.A review of manufacturing records was performed and it was found the device conformed to specification.Based on the results of the investigation, the reported issue could not be confirmed.The device functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN CRANIOTOMY KIT
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7856032
• MDR Text Key: 119553543
• Report Number: 1226348-2018-10642
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K933894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 26-1230
• Device Lot Number: HW1282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR