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

Catalog Number UNK PERFORATOR

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2018

Event Type  malfunction  

Manufacturer Narrative

Udi: unknown part number, attempts to obtain product were unsuccessful, udi unavailable.Multiple attempts to obtain additional information were not successful.Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.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 a codman perforator was being used with a stryker drill.While in use, became stuck in the patient's skull and needed to be removed.There were no reports of delay or patient harm.

• Brand Name: NI
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: karen anigbo ; 11 cabot boulevard; mansfield, MA 02048 ; 7819715608
• MDR Report Key: 8032443
• MDR Text Key: 125922866
• Report Number: 1226348-2018-10763
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK PERFORATOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1