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

Catalog Number 261221

Device Problem Insufficient Information (3190)

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

Event Date 11/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 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.

Event Description

As reported by the affiliate, a surgeon felt that a codman perforator was not working correctly, so he stopped using it, using a steel bar to complete the procedure.There were no reports of delay or patient harm.The unit will be returned.

Manufacturer Narrative

Sample was received for evaluation.The sample was visually inspected.No anomalies were observed other than that the product label was no longer present.The perforator was then functionally tested.A series of holes with drilled without issues.The device performed as intended.No lot number information has been provided; therefore, manufacturing records could not be reviewed.Based on the results of the investigation, the reported issue could not be confirmed.Trends will be monitored for this or similar complaints.

Manufacturer Narrative

It was previously reported that the device would not be returned for evaluation.The device was subsequently returned.Upon completion of the investigation, a follow-up report will be submitted.

• Brand Name: CODMAN HAKIM PROGRAMMER
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8141726
• MDR Text Key: 129604448
• Report Number: 1226348-2018-10846
• 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,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 261221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1