MAUDE Adverse Event Report: MEDICON EG AARHUS SCREW 1.6 BRACKET-HEAD 6.0/2.5/10.2MM P/5; ORTHODONTIC SCREW

Model Number	68.99.29A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Microscopic inspection of the device fragments revealed that the fracture surface clearly corresponds to a torsional fracture due to application of excessive torque.Presumably a slightly longer-than-necessary screw was used and met with increased resistance at the second cortical layer, ultimately leading to excessive torque and fracturing of the screw.The device history record was reviewed and showed no nonconformities.
Event or Problem Description
The screw broke during insertion.Emergency removal by an oral surgeon was necessary.

• Brand Name: AARHUS SCREW 1.6 BRACKET-HEAD 6.0/2.5/10.2MM P/5
• Common Device Name: ORTHODONTIC SCREW
• Manufacturer (Section D): MEDICON EG; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): MEDICON EG; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: thorsten kurz ; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 12818961
• Report Number: 8010099-2021-00001
• Device Sequence Number: 4906160
• Product Code: DZE
• UDI-Device Identifier: 04046826385460
• UDI-Public: 04046826385460
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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 Model Number: 68.99.29A
• Device Lot Number: 101568-230719
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown