MAUDE Adverse Event Report: KAVO DENTAL GMBH SMARTMATIC PROPHY S33; DENTAL HANDPIECE

Model Number SMARTMATIC PROPHY S33

Device Problems Use of Device Problem (1670); Dent in Material (2526); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/15/2024

Event Type  malfunction  

Event Description

During the palatally polishing of the teeth, the insert with the polishing attachment came loose and fell into the patient's throat, whereupon he swallowed it.An x-ray of the thorax was taken for clarification.No further medical intervention was needed.

Manufacturer Narrative

The product was delivered without the gear insert which fell into patients mouth, hence a testrun was not possible.This insert is normally screwed into the instruments head and locked by a defined torque.However the visual inspection showed that the head had several dents and nicks around the location where the insert should be placed.This shows that the instrument received several hits from external, e.G.Dropping during reprocessing.Such hits cause that the insert gets unlocked.If the instrument is then used further, the insert can be unscrewed further and further until it finally falls out, which was obviously the case here.A repair history cannot be provided by the user, which in the worst case means that the product has been in use for 4.5 years without being checked / repaired in a certified workshop.To avoid such incidents the instruction for use contains already several warnings, notes and instruction how to maintain and prepare the product prior to each use: 2.2 technical condition a damaged device or components could injure patients, users and third parties.>> only operate devices or components if they are undamaged on the outside.>> check that the device is working properly and is in satisfactory condition before each use.>> have parts with sites of breakage or surface changes checked by the service.>> if the following defects occur, stop working and have the service personnel carry out repair work: - malfunctions - damage - irregular running noise - excessive vibration - overheating - tool is not seated firmly in the handpiece.2.5 service and repair repairs, servicing and safety checks may only be performed by trained service personnel.Observe all the following items during servicing work: >> have the service and testing tasks carried out according to the medical product operator ordinance.>> following expiry of the warranty, have the tool holding system checked once a year.>> kavo recommends specifying in-house service intervals where the medical device is brought to a professional shop for cleaning, servicing and a function check.Define the service interval depending on the frequency o use.

• Brand Name: SMARTMATIC PROPHY S33
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• Manufacturer (Section G): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach / riss, 88400 ; GM 88400
• MDR Report Key: 19086327
• MDR Text Key: 340599755
• Report Number: 3003637274-2024-00010
• Device Sequence Number: 1
• Product Code: EFA
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K163239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/11/2024

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 Operator: Health Professional
• Device Model Number: SMARTMATIC PROPHY S33
• Device Catalogue Number: 1.011.6800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other