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

Catalog Number UNK PERFORATOR

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the affiliate, a codman perforator came apart where the shank is connected to the chuck of the hand drill and was unable to be re-attached ed to the hand drill.The bit had to be removed by hand.There is no report of further intervention needed or injury to the patient.

Manufacturer Narrative

Complaint sample was not returned to codman and no valid 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.Complaint will be closed as 'no complaint sample returned to codman for evaluation'.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
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7889312
• MDR Text Key: 120730931
• Report Number: 1226348-2018-10662
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK PERFORATOR
• Device Lot Number: INS5HND
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1