MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC #9 DEAN SCISSORS; SCISSORS, SURGICAL TISSUE, DENTAL

Model Number S9

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

At the time of this report, the device was not returned to hu-friedy.Since the device was not returned, as part of the evaluation, returns history for the device part code was reviewed and was noted to have a downward trend since (b)(6) 2018 and none of those s9 scissors returned were manufactured in 2019.Due to the low return and complaint rate and since a detailed evaluation could not be performed because of no instrument returned, no further action was taken.Should the device be returned, a detailed evaluation will be done, and a follow-up report will be submitted.

Event Description

It was reported that while suturing at the end of a dental implant procedure, the dean scissors broke at the hinge and the tip extension of one side fell down the patient's throat.The use of the dean scissors during a dental implant procedure is to cut 3.0 chromic suture at the end of the procedure.A pharyngeal curtain was used throughout the procedure until the actual suturing portion.Following unsuccessful retrieval attempt by direct visualization with mcgill forceps, the patient was transferred first to the local hospital, then to a tertiary care hospital, where the instrument was retrieved endoscopically under general anesthesia.There was no report of any complications following this event.

• Brand Name: #9 DEAN SCISSORS
• Type of Device: SCISSORS, SURGICAL TISSUE, DENTAL
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618 5935
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618 5935
• Manufacturer Contact: stephanie wasielewski ; 3232 n rockwell st; chicago, IL 60618-5935 ; 8472574500
• MDR Report Key: 9376258
• MDR Text Key: 168431783
• Report Number: 1416605-2019-00018
• Device Sequence Number: 1
• Product Code: EGN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S9
• Device Catalogue Number: S9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR