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

Catalog Number 26-1222

Device Problem Peeled/Delaminated (1454)

Patient Problem No Information (3190)

Event Date 02/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon completion of the investigation, a follow up report will be filed.

Event Description

As reported by the ous affiliate, on 4 perforators, the labels detached from the devices when they were irrigated.The devices were replaced with like product; no patient adverse consequences were reported.The devices are being returned.Per rep, a delay of 20 minutes was reported.

Manufacturer Narrative

Upon completion of the investigation it was noted that the evaluation revealed the following.Three perforators returned for evaluation.All 3 perforators had visible lot numbers on the label.Two had lot number: lj014s.Manufactured november 2016 at the (b)(4) facility.One had lot number cj003s manufactured march 2016 at (b)(4).All 3 had the product label rubbed off to some degree: 1 had the top 2/3rd partially rubbed off, adhesive still present.One had top ½ partially rubbed off, adhesive still present.One had middle 1/3 partially rubbed off, adhesive still present.All 3 appear to have been used.Visible apparent red blood and debris on inner and outer drill components.Unsure if ¿irrigation¿ is a standard practice and what it entails.Marks around the circumference of the label indicate the device was spinning.Appears some mechanical friction caused the labels to rub off in some areas.Does not appear that the label detached, adhesive present on all 3 perforators.The labels do not appear to have been defective.No cause can be found for the complaint.A review of the device history records for lj014s and cj003s did not reveal any anomalies during manufacturing processes.We will continue to monitor for this or similar complaints for this product code.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; new bedford industrial park; new bedford MA 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6409070
• MDR Text Key: 70081829
• Report Number: 1226348-2017-10159
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1222
• Device Lot Number: GJ003S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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