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

Catalog Number 26-1221

Device Problems Mechanical Problem (1384); Sticking (1597)

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

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

Udi - (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 and caused a dural tear.The product was used for a sta-mca.The surgery was continued, but the patient outcome is unknown.No further information was provided by the hospital.The product will be returned to your site.

Manufacturer Narrative

Udi (b)(4).Additional information: the device was returned for evaluation.The perforator was visually inspected.No anomalies were observed.Functional testing was then performed.A series of holes were drilled without issue.The device functioned as intended.A review of manufacturing records found no anomalies when the device was released to stock.Based on the results of the investigation, the reported issue could not be performed.The device functioned as intended.Trends will be monitored for this and similar complaints.At present, we consider this compliant to be closed.

Manufacturer Narrative

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

• 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: 7663849
• MDR Text Key: 113195444
• Report Number: 1226348-2018-10490
• 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: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• 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: HP0437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Date Manufacturer Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention