MAUDE Adverse Event Report: DENTSPLY LLC AUTOMATRIX REFILL MT; INSTRUMENTS, DENTAL HAND

Catalog Number	62422510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On this event it is reported that automatrix broke during use.No injury occurred.
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
Investigation findings: return.2-15-2024: returned product was 1 unit of item# 62422510 automatrix refill mt received in original packaging identified as batch# 04216480 containing only 13 of the original 72 medium thin matrix bands.The problem ¿several dies broke in the same place " could not be duplicated to the returned bands returned by using standard testing protocol on all 13 bands.These tests included a functional test, which is to tighten the matrices around a tooth model using an automate flexshaft tool; a torque test ¿tear out¿ (if applicable), which is measuring the amount of torque needed for failure; and a visual inspection for abnormalities as per 0290-ip-7.5-42-03.Each of the 13 bands were tested for ¿tear out¿ using calibrated torque gauge gle1409 with all 13 bands meeting requirement of meeting or exceeding 10 in.Oz.Force before band breaks (worst case 13 in.Oz.Force, best case 15 in.Oz.Force).All bands tested were found to be within our normal standards and meet all form/fit/function of the device.Dhr and retain evaluation will be conducted.(nwv) retain.2-15-2024: retains are not available for review as final packaging retains are not kept as per normal procedure.Retains for item# 1716601 batch# 02739638 are not available for review as per 0290-wi-8.2-07 which states retention samples must be maintained for a minimum of six months (produced 05-2021).(nwv).Dhr.2-15-2024: dhr for item# 62422510 batch# 04216480 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any issues during the execution of the packaging work order for automatrix refilll mt.Batch# 04216480 is the final packaging order which utilized bands manufactured on batch# 02739638 for item# 1716601 band assy matrix ¼ x.0015.Dhr for item# 1716601 batch# 02739638 has also been pulled, reviewed, and attached to this case.Dhr review did not indicate any issues during the execution of the matrix band assembly production work order, with all processing steps and inspections deemed acceptable by the operator(s) and quality as per 0290-wi-7.5-42-03 & 0290-ip-7.5-42-03.Per the ip, for item# 1716601 a ¿tear out¿ functional/destructive test is required on n=3 bands per machine every 2 hrs.This test requires a calibrated torque watch to record at what in.Oz.Force does the band break.The requirements are to meet or exceed 10 in.Oz.Force.All samples tested for this requirement were documented as pass.(nwv).

• Brand Name: AUTOMATRIX REFILL MT
• Common Device Name: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18520656
• Report Number: 2515379-2024-00003
• Device Sequence Number: 7587756
• Product Code: DZN
• UDI-Device Identifier: D010624226011
• UDI-Public: D010624226011
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/26/2024

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: 62422510
• Device Lot Number: 4216480
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/16/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown