MAUDE Adverse Event Report: SHOFU DENTAL CORP. SHOFU BROWNIE CUPS; POINT, ABRASIVE

Model Number 0411

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problems Laceration(s) (1946); Injury (2348); Foreign Body In Patient (2687)

Event Date 12/13/2012

Event Type  Injury  

Event Description

Initial reporter contacted shofu dental corp on (b)(6) 2012 with info regarding an injury to a dental patient while using one of our abrasives.The injury occurred on (b)(6) 2012.Initial reporter stated that while using one of shofu's abrasives at slow speed with water on tooth number 30, the silicone portion of the abrasive broke apart from the shank, lacerating the patient's mouth.Initial reporter observed that the stainless steel shank was bent and recalled hearing a loud popping sound just before the abrasive came apart.The site of the injury required the use of a topical and gauze to stop bleeding with the use of antibiotics as a follow up.Pt returned on (b)(6) 2012, complaining of pain at the site of the injury.Pt was then referred to an oral surgeon for removal of a piece of the broken abrasive from the site of the injury.Initial reporter refused to send broken (suspect) abrasive to shofu, sending a picture and the container from which the broken abrasive was taken along with two add'l unused abrasives that allegedly came from the same container.Pt fully recovered and the picture and one of the two extra unused abrasives were sent to the manufacturer.

Manufacturer Narrative

Without being able to evaluate the suspect device, manufacturer can only assume that the user exceeded performance specifications of max 30,000 speed which created large centrifugal force thus bending the shank and breaking the abrasive.In general, high speed rotation typically causes this event with dental abrasives.

• Brand Name: SHOFU BROWNIE CUPS
• Type of Device: POINT, ABRASIVE
• Manufacturer (Section D): SHOFU DENTAL CORP.; 11 kamitakamatsu-cho; fukuine; higashiyama-ku ; JA
• Manufacturer (Section G): SHOFU DENTAL INC; 11 kamitakamatsu-cho, fukuine; higashiyama-ku ; JA
• Manufacturer Contact: 11 kamitakamatsu-cho, fukuine; higashiyama-ku 605-0-983 ; 8175561041
• MDR Report Key: 3628678
• MDR Text Key: 18806963
• Report Number: 2916735-2014-00001
• Device Sequence Number: 1
• Product Code: EHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/03/2014,12/18/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0411
• Device Catalogue Number: 0411
• Device Lot Number: 1005254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2014
• Distributor Facility Aware Date: 12/18/2012
• Event Location: Other
• Date Report to Manufacturer: 02/03/2014
• Date Manufacturer Received: 12/18/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR