MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA GENERAL SCREWED STEM EXTRACTOR M8

Model Number	01.10.10.003
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 14-apr-2023.Lot 105239: (b)(4) items manufactured and released on 31-mar-2010.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.Preliminary investigation performed by r&d project manager.Having no pictures of the broken screwed stem extractor m8 ref.01.10.10.003 lot.105239, we do not have enough elements for a definitive analysis.This instrument is highly stressed during use in the surgical technique, we can assume a breakage due to wear as it is a 2010 batch with 13 years of use.
Event or Problem Description
When the surgeon was trying to extract the stem with the stem extractor, the surgeon threaded the extractor and started hammering it out and the tip broke and remained in the stem.The surgeon attempted to remove the instrument tip for 2 hours in various ways and could not remove it.The surgeon completed the surgery and closed the patient up.There was a 2-hour delay and additional anesthesia was administered.A consignment set was used.

• Brand Name: QUADRA GENERAL SCREWED STEM EXTRACTOR M8
• Common Device Name: STEM EXTRACTOR
• 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: 16807311
• Report Number: 3005180920-2023-00301
• Device Sequence Number: 6130407
• Product Code: LHX
• UDI-Device Identifier: 07630040739337
• UDI-Public: 07630040739337
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

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: 01.10.10.003
• Device Catalogue Number: 01.10.10.003
• Device Lot Number: 105239
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2010
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 127 KG