MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN¿ TAPERED IMPLANT SURGICAL ADAPTOR; HAHN TAPERED IMPLANT SURGICAL ADAPTOR

Model Number 70-1071-SRG0089

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.If/when the device is returned an investigation will be carried out and a supplemental report will be submitted.The patients date of birth was not provided when asked.This information was not provided when asked.The patients weight is not provided when asked.This information not provided when asked.This information was not provided when asked.This information was not provided when asked.The complete device information was not provided when asked.Is not applicable as the device is not implantable.The complete device information was not provided when asked.

Event Description

It is reported by the provider that the o-ring "gave-out" and the surgical adapter fell off the torque wrench and down the patients throat.

Manufacturer Narrative

The device has not been returned.However, the device investigation has been completed and the results are as follows: dhr results lot information not provided - dhr could not be reviewed.Stock product reviewed results lot information not provided - stock product could not be reviewed.Investigation methods/results attempts to retrieve the device or determine the status of the device have been made but to no avail.However, the non-visual device investigation has been completed.Root cause a root cause for this complaint cannot be explicitly determined.It is unknown how the customer stored and handled the surgical kit.Additionally, it is unknown if the customer followed the cleaning protocols as listed in user manual 6539 rev.4.0 (hahn tapered implant guided surgery manual).Per user manual 6539 rev.4.0 (hahn tapered implant guided surgery manual), the instrumentation section notes: "all instruments should be cleaned, disinfected, and sterilized according to a validated method prior to use in the oral environment.· cleaning: wash using a broad-spectrum cleaning solution, followed by thorough rinsing and drying.The recommended disinfection process is based on ansi/aami st79 guidelines, as follows: · disinfection: immerse in disinfectant,1 rinse with distilled water, and dry.The recommended sterilization process is based on the ansi/aami/iso 17665-1 and ansi/aami st79 guidelines, as follows: · sterilization: gravity-fed sterilizers: autoclave in sterilization pouch for 15 minutes at 132° c (270° f).Allow sterilized components to dry for at least 30 minutes." additionally, user manual 6539 rev.4.0 (hahn tapered implant guided surgery manual) list the following in the general cleaning information section: · observe universal precautions for the handling of contaminated or biohazardous materials.· clean promptly after each use, to prevent biological fluids and tissues from drying on the instruments.· when applicable, disassemble parts and instruments prior to cleaning.· do not rely solely on automatic cleaning.Thorough manual cleaning is recommended.· preliminary cleaning should consist of wiping parts, soaking them in a lukewarm enzymatic solution for a minimum of twenty (20) minutes and rinsing them with running water.· routine cleaning should consist of (a) washing parts using a broad-spectrum cleaning solution, followed by thorough rinsing and drying; and (b) sonicating parts fully submerged in cleaning solution for at least ten (10) minutes, preferably at 45-50 khz, followed by thorough rinsing and drying.· dry promptly and completely to avoid oxidation.

• Brand Name: HAHN¿ TAPERED IMPLANT SURGICAL ADAPTOR
• Type of Device: HAHN TAPERED IMPLANT SURGICAL ADAPTOR
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer Contact: herbert crane ; 2144 michelson drive; irvine, CA 92612 ; 9495021907
• MDR Report Key: 13112916
• MDR Text Key: 284646819
• Report Number: 3011649314-2021-00500
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 70-1071-SRG0089
• Device Catalogue Number: 70-1071-SRG0089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention