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

Catalog Number	689928A
Medical Device Problem Codes	Fracture (1260); Dent in Material (2526); 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 inspection.The outer rim of the screw head was severely deformed and half of the screw drive was broken off.Testing was performed on three identical screws from another batch to determine the force required to produce a similar fracture by means of the regular screw tightening process.As the force increased, the screw head was hollowed out by the driver, stripping the screw completely without breaking it.The type of damage was completely different.The test results indicate that when the correct procedure for screw insertion is followed, application of excessive force will not produce the type of damage shown by the returned screw.Prior to inserting a screw, it must be aligned correctly in the screwdriver sleeve.If it is inserted in the sleeve in a slanted position, the line of insertion may also be angled, damaging the outer rim of the screw head and making complete insertion impossible.Presumably that is what occurred in this case to cause the deformation of the outer rim of the screw head.And when the healthcare provider attempted to remove the screw with forceps, a fragment of the screw head broke off as described.
Event or Problem Description
The orthodontic screw head broke as the screw was being removed from the patient's jaw.The broken piece was retrieved immediately and screw removal was completed.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: 8055091
• Report Number: 8010099-2018-00002
• Device Sequence Number: 16581399
• Product Code: DZE
• UDI-Device Identifier: 04046826385446
• UDI-Public: 4046826385446
• 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: 689928A
• Device Lot Number: 094546/300415
• 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