MAUDE Adverse Event Report: MEDICON E.G. AARHUS SCREW; ORTHODONTIC SCREW

Catalog Number	689930A
Medical Device Problem Codes	Fracture (1260); Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The screw was subject to visual and microscopic inspection.It had broken at the second thread close to the screw head.The screw head profile showed clear signs of stress, indicating that a high torque was applied with the screwdriver.The fracture site itself showed an alveolar, circular fracture pattern.The fracture was a torsional fracture caused by screw overloading.The screw broke while it was being inserted into the bone.During insertion of a screw into bone, the torsional force increases with every turn.The screw fractured at the spot where the torsional force is translated from the tip of the thread to the shaft.When a screw is overwound it always fractures at this point.Overwinding occurs when the torsion force produced by the screwdriver is increased although the screw cannot be inserted any further.The screw has reached its point of maximal fixation in the bone, the user does not recognize this and continues turning the screw although the bone is too hard for insertion of the full screw length without predrilling.Manufacturing records were reviewed and showed no deviations from specifications.The fracture was due to user error.
Event or Problem Description
The orthodontic screw broke as it was being inserted into the patient's jaw.The broken piece was removed immediately.No harm to patient.

• Brand Name: AARHUS SCREW
• Common Device Name: ORTHODONTIC SCREW
• Manufacturer (Section D): MEDICON E.G.; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 8055191
• Report Number: 8010099-2018-00001
• Device Sequence Number: 1437946
• Product Code: DZE
• UDI-Device Identifier: 04046826385484
• UDI-Public: 4046826385484
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K041527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2018

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: 689930A
• Device Lot Number: 094283//200115
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 11/09/2018
• 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