MAUDE Adverse Event Report: ORTHOPEDIATRICS CANADA ULC FASSIER-DUVAL TELESCOPIC IM SYSTEM; HANDLE ASSEMBLY

Catalog Number	MR320
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor from (b)(6) reported that the male retriever (mr300) could not be disassembled after surgery.The handle assembly, tube, and coil-puller could not be removed, the release key could not be inserted, and the mechanical assembly was loose.Insertion of the torque handle did not allow rotation.The event resulted in a delay of more than 30 minutes.
Additional Manufacturer Narrative
The distributor from (b)(6) reported that the male retriever (mr300) could not be disassembled following surgery, as the handle assembly, tube, and coil puller could not be removed, the release key could not be inserted, the mechanical assembly appeared loose, and insertion of the torque handle did not allow rotation.Despite these issues, the procedure was completed successfully, and the implant was removed and replaced.Additional information clarified that the device was used for the first time after purchase and was sterilized in accordance with the ifu using steam sterilization at 132°c for 4 minutes.During assembly, the scrub nurse noted a gap between the plastic handle component and the metal cap, indicating incomplete assembly, but the device was nevertheless used, and implant removal proceeded without difficulty.After removal, the scrub nurse was unable to remove the coil puller tube together with the implant or disassemble the device.Upon return and evaluation at orthopediatrics canada, it was confirmed that the tube, coil puller, and implant could not be separated.Further inspection identified that the end of the coil puller tube was broken and that the coil puller was excessively deformed beyond normal use conditions.According to the distributor, a t-handle was used to operate the device instead of the specified mrt torque-limiting handle.Unlike the mrt handle, the t-handle does not limit applied torque, which can result in excessive force leading to deformation of the coil puller and fracture of the coil puller tube, preventing the release mechanism from functioning as intended and making disassembly impossible.The observed assembly issue involving the plastic handle is consistent with previously reported complaints.Prior investigations established that the mr320 plastic handle met all dimensional and functional specifications at the time of release, with no manufacturing, material, or incoming inspection nonconformities identified.It was confirmed that three existing lots of this instrument were manufactured in total: d393-02 ((b)(4) parts, released on february 9, 2022), e315-008 ((b)(4) parts, released on april 10, 2023), and g013-03 ((b)(4) parts, released on september 17, 2024).All lots were produced by the same supplier under the same conditions, using the same material sourced from a single supplier, and review of the certificates of conformance verified that all lots had material with identical properties.In addition, production and inspection records confirmed that functional assembly testing was successfully performed at receipt for all lots.These findings support the conclusion that the dimensional change of the plastic handle developed during use rather than being present at the time of manufacture or release, with the issue remaining limited to lot g013-03.It is also noted that the plastic handle provides ergonomic support only and does not affect the functional performance of the device, and the instrument can be used without it if necessary.Based on the available information, the device functioned as intended during implant removal, with no issues reported during extraction, and the inability to disassemble the device is attributed to mechanical deformation caused by the application of excessive torque due to the use of a non-specified t-handle.

• Brand Name: FASSIER-DUVAL TELESCOPIC IM SYSTEM
• Common Device Name: HANDLE ASSEMBLY
• 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: 25533489
• Report Number: 3000327445-2026-00004
• Device Sequence Number: 15781103
• Product Code: HWB
• UDI-Device Identifier: 07540194013095
• UDI-Public: (01)07540194013095(10)G013-03
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 06/17/2026

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: MR320
• Device Lot Number: G013-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown