MAUDE Adverse Event Report: MEDICON E.G. SCREWDRIVER BLADE

Catalog Number	75.23.39
Medical Device Problem Codes	Fracture (1260); Use of Device Problem (1670)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the returned product revealed that the screwdriver blade broke when the user attempted to forcibly release the sleeve designed to hold the implant screw securely during the insertion process.The sleeve had been overtightened by the user during implant preparation, causing the clamp jaws of the sleeve to become firmly lodged on the screw head and making it impossible for the user to release the sleeve using the dedicated screwdriver.Ultimately, the excess force applied to the screwdriver blade caused it to break.Use of another instrument was required to forcibly release the sleeve.Manufacturing history for the product was reviewed and found to be conforming to specifications.No similar complaints have been received for this product.Cause has been established as user error due to incorrect assembly of the sleeve during implant preparation.
Event or Problem Description
After successful implantation of an orthodontic screw, the user attempted to remove the implantation sleeve using the dedicated screwdriver.However, the sleeve was firmly lodged on the screw head, the screwdriver blade broke, and another instrument was required to forcibly remove the sleeve.The orthodontic screw also broke in the process (manufacturer report #2019-00003).

• Brand Name: SCREWDRIVER BLADE
• Common Device Name: SCREWDRIVER BLADE
• Manufacturer (Section D): MEDICON E.G.; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 8230639
• Report Number: 8010099-2019-00004
• Device Sequence Number: 204288
• Product Code: DZE
• UDI-Device Identifier: 04046826385583
• UDI-Public: 04046826385583
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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: 75.23.39
• Device Lot Number: 11W
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 01/09/2019
• 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