MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH IMPLANT DRIVER EXTENDER; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	68015197
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section h6 was done based on the information provided by the initial reporter.Product return is requested and product will be evaluated after receipt.
Event or Problem Description
In this event it is reported that implant drill extender came out and the patient swallowed the drill.Reportedly, the device was expelled out in the stool.An adverse form is being sent to the customer for completion.They are asking for a response to their complaint.
Additional Manufacturer Narrative
2024-03-25 pw.The implant driver extender was tested with some reference instruments and found ok.From earlier investigations we know that the friction between extender and instruments depends on handling.2024-03-27 ks explanation to investigation 1: first part of investigation 1 refers to axial forces only.Second part refers to the use of extenders together with drivers.This was just meant as an additional info.Now more details of the full investigation result: since the used drill is not available (ref.Of used drill is unk.) we took several drills from our stock and inserted them into the extender.It can be stated that a clamping can be achieved but with the different drills the strength of the clamping is perceived slightly different.When clamping was achieved and the connection respectively the drill is not touched anymore you can shake the extender and the parts don¿t separate.However, when the drill(s) receive an impulse or force from any other direction than axial, in several cases the drills just fell off, which is also matching to what the customer wrote: ¿it is ok when you push the drill in but with any vibration i.E.Drilling it often comes out.¿ we also noticed that the feeling when pushing the drill into the extender is very hard which means that the drill is stopped almost immediately after getting in contact with the flat areas.There is no smooth transition which also explains that small movements release the drill from clamping.The extender was sent to mölndal for further investigation and evaluation.

• Brand Name: IMPLANT DRIVER EXTENDER
• Common Device Name: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer (Section G): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18959194
• Report Number: 3013111692-2024-08721
• Device Sequence Number: 9446169
• Product Code: NDP
• UDI-Device Identifier: 07392532266300
• UDI-Public: 07392532266300
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 07/05/2024

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 Catalogue Number: 68015197
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/11/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EV DRILL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown