MAUDE Adverse Event Report: MEDARTIS AG APTUS; TWIST DRILL Ø1.2MM X 25MM, L81MM, AO

Model Number	A-3230
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Use of Device Problem (1670)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Event or Problem Description
Patient went to the operating room for a orif [open reduction and internal fixation], right metacarpal fracture.Medartis kit was used for implants.During the procedure four different drill bits broke and became stuck inside the patient.Surgeon was able to remove two of them, however two pieces of drill bit remained in the bone.
Additional Manufacturer Narrative
On 10th june medartis ag received a fda medsun report(b)(4) for its judgement.Up to now it is not clear, if medartis ag is in charge for this report as for the device under investigation a-3230 the brand name "provision" and udi-di (b)(4) is given by the initial report.Medartis ag sets the brand name "aptus" and use the following udi-di (b)(4).Still after several contacts to the initial report and user facility it could be not clarified why this brand name was put into the report instead of aptus.Finally, medartis ag decided to continue with the medical device reporting and investigation.Several questions were addressed to the surgeon abouth his/her surgical approach and handling of the twist drills according to the provided instructions for use/ maintance guidance on the 30th june 2025.
Additional Manufacturer Narrative
On 10th june medartis ag received a fda medsun report # 3003236702-2022-00001 for its judgement.Up to now it is not clear, if medartis ag is in charge for this report as for the device under investigation a-3230 the brand name "provision" and udi-di "(b)(4)" is given by the initial report.Medartis ag sets the brand name "aptus" and use the following udi-di "(b)(4)".Still after several contacts to the initial report and user facility it could be not clarified why this brand name was put into the report instead of aptus.Finally, medartis ag decided to continue with the medical device reporting and investigation.Several questions were addressed to the surgeon abouth his/her surgical approach and handling of the twist drills according to the provided instructions for use/ maintance guidance on the 30th june 2025.Medartis ag did not receive any response upt to the date of this report (23rd july 2025).Dhr investigation of lots delivered to the customer 16148203/17157658/22316372/24407745/25425810, i.E.Review of manufacturing and quality inspection documents, showed that all devices were manufactured acc.To specifications.The product was not forwarded to the complaint handling department to the legal manufacturer.An investigation and assessment of the surface and condition of the material itself therefore is not possible.As no specific details about the current complaint are known, the following list of possible failure reasons is based on our experience: - drills may have failed due to tear and wear during multiple uses; the surgical technique (hand-01010006_v12 / 2025-05, ) specifies a maximum usage of 10 surgeries per drill.In addition, drills are to be inspected by the user prior to use to make sure it is in good condition (corp-00000406_v3/2024-09): never use products that have been damaged by transport, improper handling in the hospital, or in any other way.After the instruments are cleaned or cleaned and disinfected, check them all for corrosion, damage to surfaces, chipping, contaminants and functionality.Remove damaged instruments.- drills may have failed due to bending of the drill (especially if used without drill guide).If the drill is bent while rotating at high speed the drill may break - if the drill is used to reposition fragments, it may fail as it is not designed accordingly - drills may have failed due to contact/collision with hard materials ( e.G.Plate, another screw, k-wire, unretrieved drill fragments, etc.); in case no drill guide was used, collision with the plate are more likely to occur.- changing angulation during drilling results in high bending forces and may ultimately result in breakage of the drill additionally, the twist drills belonging to the 1.5 system size are not meant to be used in metacarpal fractures according to our treatment concept (hand-01010006_v12_us_hand_surgical_technique).
Event or Problem Description
Patient went to the operating room for a orif [open reduction and internal fixation], right metacarpal fracture.Medartis kit was used for implants.During the procedure four different drill bits broke and became stuck inside the patient.Surgeon was able to remove two of them, however two pieces of drill bit remained in the bone.
Additional Manufacturer Narrative
On 10th june medartis ag received an fda medsun report #(b)(4) for its judgement.Up to now it is not clear, if medartis ag is in charge for this report as for the device under investigation a-3230 the brand name "provision" and udi-di "(b)(4)" is given by the initial report.Medartis ag sets the brand name "aptus" and use the following udi-di "(b)(4)".Still after several contacts to the initial report and user facility it could be not clarified why this brand name was put into the report instead of aptus.Finally, medartis ag decided to continue with the medical device reporting and investigation.Several questions were addressed to the surgeon abouth his/her surgical approach and handling of the twist drills according to the provided instructions for use/ maintance guidance on the 30th june 2025.Medartis ag did not receive any response upt to the date of this report (23rd july 2025).Dhr investigation of lots delivered to the customer 16148203/17157658/22316372/24407745/25425810, i.E.Review of manufacturing and quality inspection documents, showed that all devices were manufactured acc.To specifications.The product was not forwarded to the complaint handling department to the legal manufacturer.An investigation and assessment of the surface and condition of the material itself therefore is not possible.As no specific details about the current complaint are known, the following list of possible failure reasons is based on our experience: drills may have failed due to tear and wear during multiple uses; the surgical technique (hand-01010006_v12 / 2025-05, ) specifies a maximum usage of 10 surgeries per drill.In addition, drills are to be inspected by the user prior to use to make sure it is in good condition (corp-00000406_v3/2024-09): never use products that have been damaged by transport, improper handling in the hospital, or in any other way.After the instruments are cleaned or cleaned and disinfected, check them all for corrosion, damage to surfaces, chipping, contaminants and functionality.Remove damaged instruments.Drills may have failed due to bending of the drill (especially if used without drill guide).If the drill is bent while rotating at high speed the drill may break if the drill is used to reposition fragments, it may fail as it is not designed accordingly drills may have failed due to contact/collision with hard materials ( e.G.Plate, another screw, k-wire, unretrieved drill fragments, etc.); in case no drill guide was used, collision with the plate are more likely to occur.Changing angulation during drilling results in high bending forces and may ultimately result in breakage of the drill.Additionally, the twist drills belonging to the 1.5 system size are not meant to be used in metacarpal fractures according to our treatment concept (hand-01010006_v12_us_hand_surgical_technique).
Event or Problem Description
Patient went to the operating room for a orif [open reduction and internal fixation], right metacarpal fracture.Medartis kit was used for implants.During the procedure four different drill bits broke and became stuck inside the patient.Surgeon was able to remove two of them, however two pieces of drill bit remained in the bone.

• Brand Name: APTUS
• Common Device Name: TWIST DRILL Ø1.2MM X 25MM, L81MM, AO
• Manufacturer (Section D): MEDARTIS AG; hochbergerstrasse 60e; basel, basel-city 4057 ; SZ 4057
• Manufacturer Contact: claudia zurbuchen-desantis ; hochbergerstrasse 60e; basel, basel city 4057 ; SZ 4057
• MDR Report Key: 22477540
• Report Number: 3003236702-2025-00001
• Device Sequence Number: 8040375
• Product Code: HTW
• UDI-Device Identifier: 00810041061737
• UDI-Public: 00810041061737
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: A-3230
• Device Catalogue Number: A-3230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 06/10/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/15/2025; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White