MAUDE Adverse Event Report: ORTHOPEDIATRICS CANADA ULC FASSIER-DUVAL TELESCOPIC IM SYSTEM; MALE RETRIEVER - GENERATION III

Catalog Number	MR300
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A hospital representative from the united kingdom reported an issue involving a male retriever handle (mr300).Specifically, he stated that two mechanical screws were missing and the ratchet mechanism was not functioning.As a result, the male component did not constrict around the implant during the extraction process.Due to the malfunction, the surgeon performed an osteotomy to remove the male component manually.The procedure was completed successfully; however, the event resulted in a surgical delay exceeding 30 minutes.The hospital representative provided photographs of the retriever.The representative confirmed that the screws were already missing at the start of the case.He could not determine whether the screws were lost within the hospital after the tray arrived or whether the retriever had been shipped by the distributor already missing the screws, as the distributor did not detect the missing screws before sending the tray to the hospital.The representative stated that the missing screws rendered the retriever unusable.However, it is important to note the following: · the mechanical screws only secure the metal cap in place; they do not directly affect the tool's ability to retrieve the implant.· if the screws are missing, an operator may need to manually hold the cap, but the retrieval function remains intact.· the metal cap serves primarily as a protective cover for the ratchet mechanism.Without it, manipulation becomes more difficult, but functionality is not impaired.The fact that both screws were missing simultaneously makes spontaneous loosening unlikely.A more realistic possibility is that the screws were removed or loosened by hospital staff during cleaning.However, the assembly/disassembly instructions provided by orthopediatrics canada explicitly state that these screws should not be removed under any circumstances.Based on the information provided, a definitive root cause cannot be determined.There are two plausible scenarios: 1.Screws lost during hospital reprocessing · screws removed or loosened by hospital staff during cleaning.· root cause: user error / improper handling.2.Screws missing before shipment · screws lost by the distributor prior to shipment.· root cause: improper reprocessing by distributor leading to an incomplete instrument being sent to the hospital.Due to the lack of traceable information from the hospital, the exact cause cannot be confirmed.But because the surgeon performed an additional osteotomy, and the event caused a surgery delay > 30 minutes, the incident will be reported to fda and mhra.
Event or Problem Description
A hospital representative from the united kingdom reported an issue involving a male retriever handle (mr300).Specifically, he stated that two mechanical screws were missing and the ratchet mechanism was not functioning.

• Brand Name: FASSIER-DUVAL TELESCOPIC IM SYSTEM
• Common Device Name: MALE RETRIEVER - GENERATION III
• Manufacturer (Section D): ORTHOPEDIATRICS CANADA ULC; 1111 autoroute chomedey; laval, quebec H7W5J 8; CA H7W5J8
• Manufacturer (Section G): ORTHOPEDIATRICS CANADA ULC; 1111 autoroute chomedey; laval, quebec H7W5J 8; CA H7W5J8
• Manufacturer Contact: enrique garcia ; 1111 autoroute chomedey; laval, quebec H7W5J-8 ; CA H7W5J8
• MDR Report Key: 24506262
• Report Number: 3000327445-2026-00002
• Device Sequence Number: 9870010
• Product Code: HWB
• UDI-Device Identifier: 07540194013095
• UDI-Public: (01)07540194013095(10)G013-03
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K041393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MR300
• Device Lot Number: G013-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (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 Sex: Female