MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC 11 STRAIGHT BERNARD SYNDESMOTOME

Model Number BER11

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Event Description

The user facility reported that during a dental procedure the user facility was using their 11 straight bernard syndesmotome when the tip detached resulting in a cut to the patient's tonsil area.The detached tip was retrieved from the patient's mouth.Medical treatment was administered (decadron administered via iv).

Manufacturer Narrative

Hufriedy requested the device to be returned for evaluation.However, the user facility elected to keep the device until their own investigation is complete.Without the return of the device, the cause of the reported issue cannot be determined.A 3-year complaint review indicates this to be an isolated event.A follow-up mdr will be submitted should the device be returned for evaluation.

Manufacturer Narrative

The user facility has indicated that they will not return the instrument to us for evaluation.To date, no additional information regarding the reported event has been provided.

Manufacturer Narrative

Steris became aware of user facility medwatch report number (b)(4) through our periodic review of the maude database on (b)(6) 2023.Steris confirmed that an investigation for the reported event was previously completed and mdr # 1416605-2023-00007 for the event was submitted on (b)(6) 2023.No additional issues have been reported.

• Brand Name: 11 STRAIGHT BERNARD SYNDESMOTOME
• Type of Device: SYNDESMOTOME
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer Contact: daniel davy ; 3232 n rockwell st.; chicago, IL 60618 ; 4403927453
• MDR Report Key: 17923129
• MDR Text Key: 326447819
• Report Number: 1416605-2023-00007
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 10889950004767
• UDI-Public: 10889950004767
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2023

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: BER11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 09/15/2023; 09/15/2023
• Supplement Dates FDA Received: 10/23/2023; 12/20/2023
• 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: Reuse
• Patient Sequence Number: 1