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

Catalog Number 62422603

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it is reported that automatrix shaft broke during use.No injury.

Manufacturer Narrative

Investigation results 5-22-2024: returned product 2 flexshafts date coded 0523 & 1023 with coil deformation/weld failure resulting in the device to not function properly.Capa-2023-519 opened to address flexshaft failures for product manufactured by sarasota since september 2022 (date code 0922) through present day.Item# 62422603 batch# 07790394 utilized item# 24703 batch# 07607335 (flexshaft assembly) which was produced 10-2023.The returned flexshaft date coded 0523 does not trace back to item# 62422603 batch# 07790394 and no other batch information was provided in this case, therefore only one flexshaft returned (date code 1023) has traceability and due to the nature of this case, dhr and retain evaluation will be conducted for this product.(nwv).Retain 5-22-2024: retain for item# 24703 batch# 07607335 has been pulled, inspected per 0290-wi-7.5-42-04 (with exception to destructive testing).The flexshafts were tested by using standard testing protocol.The tests included a functional test, which is to use an automate iii tool and the retain flexshaft to tighten a matrix band (n=5) around a tooth model, and a visual inspection for abnormalities.Retain meets all criteria for form/fit/function of the intended use for the device.(nwv).Dhr 5-22-2024: dhr for item# 62422603 batch# 07790394 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any issues during the execution of the packaging work order with all inspections completed and deemed acceptable by the operator(s) and quality for automatrix accessories extra shaft assembly work order.Item# 24703 batch# 07607335 is the production work order for the flexshaft in which the customer has complained against (date code 1023).Dhr for item# 24703 batch# 07607335 has also been pulled, reviewed, and attached to this case.Dhr review did not indicate any issues during the assembly work order for the flexible shaft assembly, with all inspections performed and deemed acceptable by the operator(s) and quality as per 0290-wi-7.5-42-04 & 0290-ip-7.5-42-06.Per the wi, weld testing for the 1st 10 subassemblies of every order and ever 25th subassembly is conducted and documented.Assemblies are then to bake at 180*f for 30 minutes minimum and documented.Functional test for set screw crimping conducted on the 1st assembly and every 50th assembly in the order and documented.12 in-ounce torque test is performed on 100% of the flexshafts and documented.Torque to fail test is performed every 125th flexshaft assembly and the final assembly in the order for minimum requirement of 1.25 inch-pounds and documented.(nwv).

• Brand Name: AUTOMATRIX SHAFT
• Type of Device: 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: 19182015
• MDR Text Key: 341300966
• Report Number: 2515379-2024-00021
• Device Sequence Number: 1
• Product Code: DZN
• UDI-Device Identifier: D010624226011
• UDI-Public: D010624226011
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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: 62422603
• Device Lot Number: 07790394
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/25/2024
• Initial Date Manufacturer Received: 04/25/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1