MAUDE Adverse Event Report: MEDICON EG AARHUS SCREW 1.6 BRACKET-HEAD 8.0/2.5/12.2MM P/5; ORTHODONTIC SCREW

Catalog Number	68.99.31A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fracture surface clearly corresponds to a torsional fracture due to application of excessive torque.Presumably the screw tip reached the second cortical layer and met with increased resistance since the drill hole was not deep enough.Ultimately this led to excessive torque and fracturing of the screw.The device history record was reviewed and showed no nonconformities.No similar issues have been reported in the past.Despite repeated attempts it has not been possible to obtain more information regarding the event, particularly its date and the results of subsequent surgery, if performed.Should more information become available, a follow-up report will be submitted.
Event or Problem Description
The screw broke at a depth of 5 mm during the screwing process.0.8 mm of the screw tip broke off.According to the doctor, the screw tip remains in the patient's jaw and surgery will be necessary to remove the device fragment.(device 2 of 2).

• Brand Name: AARHUS SCREW 1.6 BRACKET-HEAD 8.0/2.5/12.2MM P/5
• Common Device Name: ORTHODONTIC SCREW
• Manufacturer (Section D): MEDICON EG; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 10136828
• Report Number: 8010099-2020-00003
• Device Sequence Number: 1847774
• Product Code: DZE
• UDI-Device Identifier: 04046826385507
• UDI-Public: 4046826385507
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 06/10/2020

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: 68.99.31A
• Device Lot Number: 098992/130718
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 06/10/2020
• 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: Other