MAUDE Adverse Event Report: HANDPIECE HEADQUARTERS MAXIMA PRO 45 N/O FIXED END; HANDPIECE

Model Number MAXIMA PRO 45

Device Problems Detachment of Device or Device Component (2907); Inadequate Lubrication (4057)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/29/2022

Event Type  Injury  

Event Description

Patient appeared to have swallowed surgical bur (560l) during tori removal and alveoplasty surgery.

Manufacturer Narrative

History on the handpiece was retrieved which stated that it was purchased on 05/31/19 and was sent in for repair twice (04/13/21 for warranty repair & 11/09/21 where a new turbine was installed by handpiece headquarters).

• Brand Name: MAXIMA PRO 45 N/O FIXED END
• Type of Device: HANDPIECE
• Manufacturer (Section D): HANDPIECE HEADQUARTERS; 620 s. placentia ave.; placentia CA 92870
• Manufacturer (Section G): HANDPIECE HEADQUARTERS; 620 s. placentia ave.; placentia CA 92870
• Manufacturer Contact: frederick wang ; 620 s. placentia ave.; placentia, CA 92870 ; 7145790175
• MDR Report Key: 15522564
• MDR Text Key: 300997597
• Report Number: 3007007357-2022-00013
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAXIMA PRO 45
• Device Catalogue Number: 112-6771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• 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
• Patient Age: 63 YR
• Patient Sex: Male