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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The screw was subject to visual and microscopic inspection.During the insertion process, it had broken at the second thread close to the screw head.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.To test this scenario, three screws from another batch were subject to overload to determine the type of fracture caused by overwinding.The fracture mode of the returned screw and of the screws subject to testing to failure was similar.We therefore conclude that the returned screw broke due to user error, i.E.By overloading the screw during insertion.
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: 8055194
• Report Number: 8010099-2018-00003
• Device Sequence Number: 13866593
• Product Code: DZE
• UDI-Device Identifier: 04046826385484
• UDI-Public: 4046826385484
• 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
• 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: 094410/180915
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• 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