MAUDE Adverse Event Report: MEDICON EG SCREWDRIVER BLADE; SCREW INSERTION DEVICE

Model Number	75.23.39
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned device had not been disassembled nor cleaned after the procedure.Its four grasping blades were still holding the head portion of the tad (temporary anchorage device or orthodontic screw) positioned at a slant between them.The blades showed strong torsional damage.Upon removal of the tad from the insertion device, multiple dents were observed on the inside surface of its blades.Multiple signs of wear and reuse were found on the device overall.A separate adverse event report is being submitted for the tad.The damage shown by the insertion device has been evaluated.The grasping blades show strong torsional damage and multiple dents on their inside surfaces, which indicates that excessive force was applied during the subject event.At this point it is not possible to establish without a doubt whether the insertion device was already damaged before the event and used anyway; whether the damage was produced wholly during the event; or whether the device was slightly damaged prior to the event and additionally damaged due to excessive torque being applied during the event.Pre-existing damage of the insertion device would have contributed to incorrect alignment of the screw head between the blades, in addition to negatively affecting the angle of force.If the blades of the insertion device were deformed prior to the event it would also indicate that the device instructions for use were not followed by the user.The instructions for use clearly indicate that "in order to prevent failure or mechanical damage of the application instruments during surgery, they must always be checked before each use for mechanical integrity, full functional range, and possible deformation.Damaged instruments must be discarded." tests are currently being performed by an accredited laboratory to aid in resolving the issue and shed further light on the cause of the event.Review of the device history record has revealed neither nonconformances nor deviations during the manufacturing process.The device conformed fully to specifications upon release.As indicated above, tests are being performed by an accredited laboratory and the investigation of this event is ongoing.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
During a procedure involving placement of a temporary anchorage device (tad)/screw implant between the lower right cuspid and 1 bicuspid, the screw was grasped with the grasping blades of the screw insertion device that is the subject of this medical device report.The grasping blades were tightened to firmly hold the tad and the tad was placed.When attempting to release the tad from the insertion device, the head of the tad broke off the flute portion.The tad head remained in the grasp of the insertion device.To recover the broken flute of the tad, a flap was raised from the ridge of the missing 2" bicuspid to the distal of the cuspid and a vertical releasing incision was made over the broken tad.The flute part of the tad was located.Bone was removed circumferentially around the tad to allow the placement of a hemostat around the exposed portion of the tad.The broken tad was backed out using the hemostat.Then the flap was closed by suturing the vertical and gingival incisions together.The patient was given post op instructions, instructions for pain and a follow-up appointment.
Additional Manufacturer Narrative
The affected device was subject to evaluation by an accredited independent lab facility.The screw grasping component was found to be severely deformed, indicating overload during insertion of the screw, possibly due to user error; specifically, to faulty positioning of the screw in the insertion device.No response was received to multiple requests for additional information with regard to patient outcome and the event.The manufacturer concludes that the failure was due to user error.

• Brand Name: SCREWDRIVER BLADE
• Common Device Name: SCREW INSERTION DEVICE
• Manufacturer (Section D): MEDICON EG; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): MEDICON EG; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: thorsten kurz ; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 14516973
• Report Number: 8010099-2022-00002
• Device Sequence Number: 15111958
• Product Code: DZE
• UDI-Device Identifier: 04046826385583
• UDI-Public: 4046826385583
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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 Model Number: 75.23.39
• Device Lot Number: 11AC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MOTRIN; PERIOGUARD; TYLENOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Sex: Unknown