MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR 9MM; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number 26-1223

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Tissue Damage (2104)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).It has been reported that the device will not be returned for evaluation.A lot number has been provided.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that an injury to the dura occurred during use of the perforator.There is no report of a malfunction for the device.The injury to the dura occurred only at one point of the sagittal suture in 5 to 6 points of transformation.The cerebrospinal fluid leak after surgery was somewhat larger.Other things were within normal range.There was no bleeding, no cerebral contusion, and the patient's condition is no problem at all.It was the first time to use the product.No further information available.The product will not be returned to your site.

Manufacturer Narrative

Udi : (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 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.

• Brand Name: CODMAN DISPOSABLE PERFORATOR 9MM
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7565457
• MDR Text Key: 109934239
• Report Number: 1226348-2018-10381
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 26-1223
• Device Lot Number: HM9072
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1