MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC WAVEONE GOLD RECIPROCATING FILE PRIMARY 31MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	WGPRIME31
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
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 was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are: dhr nothing unusual to report was found during dhr review.A query indicates no additional complaints have been received for this lot number.Customer not returning, discarded.Product not received at investigation site.Failure mode: broken during use root cause: product not received at investigation site conclusion code: indeterminable.
Event or Problem Description
In this event it is reported that waveone gold reciprocating file primary 31mm broke during use.No injury.

• Brand Name: WAVEONE GOLD RECIPROCATING FILE PRIMARY 31MM
• Common Device Name: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18311436
• Report Number: 2320721-2023-00284
• Device Sequence Number: 6267176
• Product Code: EKS
• UDI-Device Identifier: D716WGPRIME311
• UDI-Public: D716WGPRIME311
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 12/12/2023

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: WGPRIME31
• Device Lot Number: 0000370049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/08/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 12/12/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown