MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL EXCAVATOR DOUBLE ENDED 13-14; EXCAVATOR, DENTAL, OPERATIVE

Catalog Number	B009501301400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event 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 : involved product that broke during use was not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1809040).Root causes are not identified.We will track this kind of event and monitor the trend.Root causes are not identified.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.
Event or Problem Description
In this event it is reported that a excavator double ended 13-14 broke during use.The outcome of this event is unknown as of this mdr.Further information requested.

• Brand Name: EXCAVATOR DOUBLE ENDED 13-14
• Common Device Name: EXCAVATOR, DENTAL, OPERATIVE
• 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19799584
• Report Number: 8031010-2024-00090
• Device Sequence Number: 7497287
• Product Code: EKC
• UDI-Device Identifier: J003B0095013014001
• UDI-Public: J003B0095013014001
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 07/22/2024

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 Catalogue Number: B009501301400
• Device Lot Number: 1809040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/10/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 07/22/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown