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

Catalog Number	62422512
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, this event meets the criteria for reportability per 21 cfr 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.
Event or Problem Description
In this event it is reported that a automatrix refill mr band broke during use.No injury occurred.
Additional Manufacturer Narrative
Investigation results: return.Returned product was 1 unit of item# 62422512 automatrix refill mr lot# 09834318 in original packing and containing 71 unused matrix bands.The problem " it was splitting at the joint on 4 occasions" could not be duplicated to the bands returned by using standard testing protocol on n=8 bands randomly selected from each lot using aql 1.5 c=0 for visual and dimensional evaluation and n=4 using aql 10.0 c=0 for destructive/functional testing.These tests included measurement of the small coil outer diameter and a functional test, which is to tighten the matrices around a tooth model using an automate flexshaft tool and a visual inspection for abnormalities as per 0290-ip-7.5-42-03 and 0290-wss-7.5-42-02.All 8 bands visual/dimensional inspections were found to be within our normal standards and meet all form/fit/function of the device.Functional testing 4 samples did not exhibit any issues/splitting/breaking and meet all form/fit/function of the device.(nwv).Retained: retains are not available for review as final packaging retains are not kept as per normal procedure.Retains for item# 1716603 lot# 09700909 were pulled and inspected/tested as per 0290-wi-7.5-42-03 & 0290-ip-7.5-42-19 & 0290-wss-7.5-42-02 and were found to meet all acceptance criteria.(nwv).Dhr: dhr for item# 62422512 lot# 09834318 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 refill mr.Work order/lot# 09834318 is the final packaging order which utilized bands manufactured on work order/lot# 09700909 for item# 1716603 (band assy matrix.25 x.0020).Dhr for item# 1716603 lot# 09700909 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-7.5-42-19 & 0290-wss-7.5-42-02.(nwv).

• Brand Name: AUTOMATRIX REFILL MR
• 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 21724187
• Report Number: 2515379-2025-00007
• Device Sequence Number: 18490416
• Product Code: DZN
• UDI-Device Identifier: D0026630021
• UDI-Public: D0026630021
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: 62422512
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/28/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown