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

Catalog Number 26-1221

Device Problem Material Separation (1562)

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

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

Udi - (b)(4).Attempts are being made to obtain additional information.Upon completion of the investigation, a followup report will be submitted.

Event Description

It was reported that the perforator label was peeling during use.The product was used for opening the first hole, and there were no anomalies confirmed during initial use.However, the nurse confirmed that a label on the blue part of the product was about to come off after second time of use.Therefore, the nurse wiped it with gauze, and it came off easily.The nurse thought that it is risky to keep using the perforator and better to avoid letting the label piece falling down into the patient's head, so the product was used only two times during the surgery, and the surgery was finished.There were no anomalies in the operation of the product.There was no surgical delay and there was no adverse consequence to the patient.No further information was provided by hospital.The product will be returned to your site.

Manufacturer Narrative

(b)(4).The device was returned for evaluation.The perforator was visually inspected.The perforator was soiled and the label was worn.Functional testing was then performed.A series of holes were drilled per the test method without issue.The device performed as intended.A review of manufacturing records found the device conformed to specification when released to stock.Based on the evaluation, it was confirmed that the product label was damaged.However, without additional information, it is not possible to determine the specific cause.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: 7782634
• MDR Text Key: 117167856
• Report Number: 1226348-2018-10572
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2018

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 Expiration Date: 02/28/2023
• Device Catalogue Number: 26-1221
• Device Lot Number: HR9145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/14/2018
• Supplement Dates Manufacturer Received: 08/23/2018; 11/20/2018
• Supplement Dates FDA Received: 09/13/2018; 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1