MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA HIP INSTRUMENTS; LONG SCREWDRIVER 5MM

Model Number	01.22.10.0134
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During revision of m-vizion stem (b)(4), the tip of the long screwdriver 5mm broke inside the screw; it could not be recovered and was left in the patient.The screw has been reported to be completely tightened and the construct seemed stable.Torque limiter was used and was reported to have reached the target torque.This is the same patient and the same torque limiter involved in (b)(4).
Additional Manufacturer Narrative
Batch review performed on 31-07-2025.Lot 2156713: (b)(4) items manufactured and released on 14-01-2022.No anomalies found related to the problem.To date, one similar event has been reported on the same lot during the period of review.
Additional Manufacturer Narrative
Correction: b5 updated additional info: batch review performed on 15-sep-2025 m-vizion 01.22.10.0118 tightening torque wrench lot 1951990: 1 item manufactured and released on 21-04-2022.No anomalies found related to the problem.To date, one similar events have been reported on the same lot during the period of review.Analysis performed by medacta hip r&d project mananger: during visual inspection, the tip of the screwdriver was found broken, and a fracture analysis revealed that the breakage was caused by excessive torque.Upon inspection, the torque limiting mechanism of the wrench reported to have been utilized, was found to be damaged.Medacta applies a 100% functional verification prior to release, and the investigation of complaint history data concludes this to be an isolated case with no trend associated or prior similar events.The device history record reviews do not indicate any potentially related manufacturing cause.
Event or Problem Description
Patient underwent surgery where m-vizion stem was implanted.During final tighthening the tip of the short screwdriver broke in the definitive screw and was left in the patient (mdr 3005180920-2025-00702).About a week after the surgery the patient underwent revision due to malpositioning (via falsa) of the stem (mdr 3005180920-2025-00718).Previous implant was removed entirely along with the broken screwdriver tip.During final tighthening the tip of the long screwdriver broke inside the screw, similarly to what happened during the first surgery.The tip could not be recovered and was left in the patient.The screw has been reported to be completely tightened and the construct seemed stable.Torque limiter used is the same of the first surgery, it was reported to have reached the target torque.
Additional Manufacturer Narrative
H6 annex c and d updated.External supplier analysis: the device concerned was manufactured and delivered in june 2019 and has since been in continuous use.Considering its age and the observed condition, including traces of impact and wear, the failure can reasonably be attributed to long-term use and environmental exposure.The internal inspection revealed that corrosion had spread throughout the mechanism, originating from the detachment of the peek bearing that compromised the sealing integrity.This seal failure likely allowed humidity ingress over time, ultimately leading to the malfunction of the torque mechanism.No similar issues have been reported for this product family, which supports the assessment of an isolated case related to ageing and extended service life.Conclusion: during visual inspection, the tip of the screwdriver was found broken, and a fracture analysis revealed that the breakage was caused by excessive torque.Upon inspection, the torque limiting mechanism of the wrench reported to have been utilized, was found to be damaged likley due to progressive wear over its useful life.Medacta applies a 100% functional verification prior to release, and the investigation of complaint history data concludes this to be an isolated case with no trend associated or prior similar events.The device history record reviews do not indicate any potentially related manufacturing cause.

• Brand Name: HIP INSTRUMENTS
• Common Device Name: LONG SCREWDRIVER 5MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22725447
• Report Number: 3005180920-2025-00722
• Device Sequence Number: 20905016
• Product Code: LXH
• UDI-Device Identifier: 07630040739191
• UDI-Public: 07630040739191
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2025

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
• Operator of Device: Health Professional
• Device Model Number: 01.22.10.0134
• Device Lot Number: 2156713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 10/01/2025; 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown