MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISP PERFORATOR 11MM; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problems Tissue Damage (2104); Patient Problem/Medical Problem (2688)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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.

Event Description

It was reported that the complaint perforator was used during a vp shunt procedure.The auto release did not work and a dural injury occurred.The patient developed mild cerebral contusion at the surface of right frontal lobe.Therefore hemostasis was made and the vp shunt procedure was performed.The procedure delayed 30 mins due to this incident.The complaint device was not re-sterilized, and it was used as per the ifu.The concomitant drill was emax2plus and the speed was 60,000 spins.There was no difference of level confirmed at the hole, but the bone pad was confirmed.The product was not inspected prior to use.The perforated bone was healthy and the thickness was 9.1 mm according to ct images.His viral is stable now.No further information was provided by the hospital.

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

The device was received for evaluation.The perforator was visually inspected, and it was heavily soiled on the inner and outer drills.The perforator was then functionally tested.A series of holes with drilled without issues.The device performed as intended.A review of manufacturing records found no discrepancies when released to stock.Based on 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 DISP PERFORATOR 11MM
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8339655
• MDR Text Key: 136160214
• Report Number: 1226348-2019-10096
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 26-1221
• Device Lot Number: HN3354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other