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 No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

(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

During use, the perforator did not disengage.There is no report of harm or delay.Another was used to complete the procedure.Cta was performed to ensure no venous thrombosis caused.

Manufacturer Narrative

The perforator was returned for evaluation.The device was visually inspected.The product label was missing from the device; no other anomalies were observed.Functional testing was then performed.A series of five holes were drilled without issue.The device functioned as intended.The reported issue could not be confirmed.A review of manufacturing records could not be confirmed, as the lot number provided was not valid for this product code.Trends will be monitored for this and similar issues.At present, we consider this complaint 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: 7441158
• MDR Text Key: 106017549
• Report Number: 1226348-2018-10290
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2018

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: Physician
• Device Catalogue Number: 26-1221
• Device Lot Number: HD5830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 05/01/2018; 05/29/2018
• Supplement Dates FDA Received: 05/07/2018; 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1