MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL CARB.B.SURGERY ZEKRYA FG 23MM; BUR, DENTAL

Catalog Number	151-FG23
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Laceration(s) (1946); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that carb.B.Surgery zekrya fg 23mm broke during use.Reportedly, this caused a 1-1.5 cm log wound found under the left side of the patient's tongue.The submandibular area and the left side of the neck were mildly swollen.The patient went to hospital.According to the patient, no bur tip was found on the x-ray that was taken.
Additional Manufacturer Narrative
As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
Additional Manufacturer Narrative
Summary: involved product that broke during use is not available and cannot be analyzed.Moreover, no unused bur is available for evaluation.Nothing unusual to report was found during dhr review (batch #1817326).Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: CARB.B.SURGERY ZEKRYA FG 23MM
• Common Device Name: BUR, DENTAL
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer (Section G): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18037985
• Report Number: 8031010-2023-00856
• Device Sequence Number: 7480809
• Product Code: EJL
• UDI-Device Identifier: J003E0151351000001
• UDI-Public: J003E0151351000001
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

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 Catalogue Number: 151-FG23
• Device Lot Number: 1817326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/24/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown