MAUDE Adverse Event Report: ORTHOFIX SRL SINGLE USE 8MM SCRAPER PROBE - 80MM - STERILE

Catalog Number	OHS2080SU
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, orthofix srl received directly from mhra information about an adverse incidents occurred in the uk market.A summary of the information is reported below: hospital name: (b)(6) hospitals , contact name: (b)(6).Reference number assigned by mhra for this incident: user report ref: (b)(4) mhra ref: (b)(4).Date of incident: on (b)(6) 2023.Nature of incident: while using the probe during surgery, for removal of cement of the femoral canal, the oscar3 unit highlighted as weak feedback.As the surgeon retrieved the probe from the femoral canal, it was noted the probe was bent and suddenly broke in two pieces.Orthofix srl ref:(b)(4).User report ref: (b)(4) mhra ref: (b)(4).
Additional Manufacturer Narrative
Orthofix srl forwarded the information received from mhra on this adverse incident to the local distributor requiring to contact the hospital involved to get further information on the event and the return of the device concerned for analysis.As soon as further information are available, orthofix srl will provide a follow up report.
Additional Manufacturer Narrative
Analysis of historical records orthofix checked the internal records related to the controls made on the device code ohs2080su batch b3331184, before the market release.No anomalies have been found.The original lot, manufactured in 2023, was comprised of 60 devices.All of them have already been distributed to the market.According to orthofix historical records, no other notifications have been received from this specific device lot.Technical evaluation the returned device, received on february 19, 2024, was examined by orthofix quality operations department.The returned device was subjected to visual and dimensional check as per orthofix specification and then sent to an external laboratory for the raw material check and failure analysis.The visual check evidenced that the single use 8mm scraper probe is broken in correspondence of the connection radius to the smallest diameter of the stem.The dimensional check, performed where possible, did not evidence any anomalies.It was not possible to perform the functional check as the device is broken.The analysis of the raw material, performed by an external laboratory, confirmed that the item is in conformity with orthofix specifications.The probe broke due to overload or impact during use leading to a fracture initiation and resulting in fatigue failure.Conclusions the results of the technical evaluation confirmed that the returned device was originally conforming to orthofix specifications.The probe broke due to overload or impact during use leading to a fracture initiation and resulting in fatigue failure.The analysis of the historical data evidenced that no other similar notifications have been received on devices belonging to the same lot.Orthofix continues monitoring the devices on the market.
Event or Problem Description
On january 4, 2024, orthofix srl received directly from mhra information about an adverse incidents occurred in the uk market.A summary of the information is reported below: hospital name: (b)(6) hospitals contact name: (b)(6) reference number assigned by mhra for this incident: user report ref: 2023/011/022/501/007 [mhra ref: 27601013-aicxml] date of incident: on (b)(6) 2023 nature of incident: while using the probe during surgery, for removal of cement of the femoral canal, the oscar3 unit highlighted as weak feedback.As the surgeon retrieved the probe from the femoral canal, it was noted the probe was bent and suddenly broke in two pieces.(b)(4).

• Brand Name: SINGLE USE 8MM SCRAPER PROBE - 80MM - STERILE
• Common Device Name: SINGLE USE 8MM SCRAPER PROBE - 80MM - STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer Contact: gianluca ricadona ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 18510389
• Report Number: 9680825-2024-00001
• Device Sequence Number: 20729903
• Product Code: JDX
• UDI-Device Identifier: 18056099649780
• UDI-Public: (01)18056099649780(11)230531(17)280404(10)B3331184
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

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 Catalogue Number: OHS2080SU
• Device Lot Number: B3331184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 90 KG