MAUDE Adverse Event Report: MEDICON E.G. AARHUS SCREW 1.6 BRACKET HEAD; ORTHODONTIC IMPLANT SCREW

Catalog Number	68.99.30A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the returned product revealed that the sleeve, which is designed to hold the screw securely during the insertion process, was overtightened by the user during implant preparation.The excess stress warped the clamp jaws of the sleeve, causing them to become firmly lodged on the screw head.The dedicated screwdriver blade broke when the user attempted to remove the sleeve as intended.A deep groove on the sleeve indicates that a grasping instrument such as pliers was required to remove the sleeve, severely damaging the screw head and fracturing the implant.The broken-off tip of the screw implant has not been returned by the user and is not available for investigation, making it impossible to reach a definite conclusion regarding the cause of the screw fracture.However, conceivably the implant broke due to the excess force required to remove the sleeve that had been assembled incorrectly by the user.Manufacturing history for the product was reviewed and found to be conforming to specifications.No similar complaints have been received for this product.(b)(4).
Event or Problem Description
The orthodontic screw broke after successful implantation when the user attempted to remove the implantation sleeve using the dedicated screwdriver.However, the sleeve was firmly lodged on the screw head, the screwdriver blade broke, and another instrument was required to forcibly remove the sleeve.
Additional Manufacturer Narrative
The doctor stated that she discarded the broken-off tip of the screw implant.Inspection by the manufacturer is therefore not possible.
Event or Problem Description
The doctor has reported that she removed the broken-off tip (approximately 2 mm) of the orthodontic screw with tweezers and placed a new implant.The patient is fine.

• Brand Name: AARHUS SCREW 1.6 BRACKET HEAD
• Common Device Name: ORTHODONTIC IMPLANT SCREW
• Manufacturer (Section D): MEDICON E.G.; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 8221831
• Report Number: 8010099-2019-00003
• Device Sequence Number: 207266
• Product Code: DZE
• UDI-Device Identifier: 04046826385484
• UDI-Public: 04046826385484
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K041527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 68.99.30A
• Device Lot Number: 094884/020916
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention