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

Catalog Number 26-1221

Device Problem Mechanical Problem (1384)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

Udi - (b)(4).Attempts are being made to obtain additional information.Upon receipt of additional relevant information, a follow-up report will be submitted.This is device 1 of 2 reported in this event.Refer to mdr 1226348-2018-10805 for information on the additional device.

Event Description

This is complaint 1 out of 2 that was reported by the affiliate, a perforator disengaged prematurely causing a 45 minute delay.The procedure was concluded with a helical cutter.The patient was awake because he was undergoing to dbs for parkinson's disease and he complained strongly about the prolonged and annoying maneuver.

Manufacturer Narrative

Udi: (b)(4).It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were unsuccessful.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 that the device conformed to specification when released.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, 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
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8046432
• MDR Text Key: 126398931
• Report Number: 1226348-2018-10804
• 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
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• 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: 26-1221
• Device Lot Number: HW3904
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other