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

Catalog Number 26-1221

Device Problem Mechanical Problem (1384)

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

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).It has been reported that the device will be returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that the perforator failed to disengage, this occurred on the 4th burr hole done during this surgery, and there was dural tearing injury to the brain tissue.The surgery was for removal of a brain tumor.The surgeon felt the device get through the skull but the rotation did not stop.The physician attempted to pull the drill system back; however, the perforator caught on the skin flap and then came out of the b.Braun drill system and fell onto the dura.The surgeon felt that something wrong with the shaft wobbling when connecting the product to the drill system.No further information was provided by hospital.The product will be returned to your site.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Udi : (b)(4).The device was returned for evaluation.The perforator was visually inspected.No anomalies were observed other than slight wear on the product label, which would not affect performance.Functional testing was then performed.A series of five holes were drilled without issue.The device functioned as intended.A review of manufacturing records found no discrepancies when the device was released to stock.Based on the results of the investigation, the reported issue could not be confirmed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be 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
• MDR Report Key: 7466119
• MDR Text Key: 106698347
• Report Number: 1226348-2018-10307
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 26-1221
• Device Lot Number: HQ1359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention