MAUDE Adverse Event Report: TORNIER S.A.S. ASCEND FLEX RETROVERSION ROD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	MWF113
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition.
Event or Problem Description
It was reported that the disengagement of the distal body of the trial stem from the proximal body, with the retroversion rod still attached to the introducer handle.The procedure was completed successfully by fracturing the humerus proximally, removing the remaining part of the trial stem inside and re-trailing with a new construct, followed by the final implant.This resulted in a 45 min delay.
Event or Problem Description
It was reported that the disengagement of the distal body of the trial stem from the proximal body, with the retroversion rod still attached to the introducer handle.The procedure was completed successfully by fracturing the humerus proximally, removing the remaining part of the trial stem inside and re-trailing with a new construct, followed by the final implant.This resulted in a 45 min delay.
Additional Manufacturer Narrative
Please note corrections to the h6 health impact code: the reported event could be confirmed, since the device was returned for evaluation, and matches the alleged failure.The device inspection revealed the following: visual inspection: a visual inspection of the retroversion rod indicates that the threaded end has sheared off.The fragment remains in the handle in positioning option hole number 20.Medical expert opinion: the x-ray shows a distal humeral component in place with part of the metaphysis trial piece still attached to it, explaining its unusual proximal contours.I can image with the snapped center screw still in place that a bone splitting window was necessary to remove the trial stem.The retroversion rod snapping from the handle is most likely caused by hitting it with a hammer (or manual force).The rod is only fixed for version reference, and no force should be applied on it.Based on the investigation and provided information, the root cause was attributed to a user-related issue.The broken end of the device was caused by the application of excessive torque or from a forceful impact that caused the rod to shear as it was attached to the handle.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.
Additional Manufacturer Narrative
Please note correction to b1, d9/h3.
Event or Problem Description
It was reported that the disengagement of the distal body of the trial stem from the proximal body, with the retroversion rod still attached to the introducer handle.The procedure was completed successfully by fracturing the humerus proximally, removing the remaining part of the trial stem inside and re-trailing with a new construct, followed by the final implant.This resulted in a 45 min delay.
Event or Problem Description
It was reported that the disengagement of the distal body of the trial stem from the proximal body, with the retroversion rod still attached to the introducer handle.The procedure was completed successfully by fracturing the humerus proximally, removing the remaining part of the trial stem inside and re-trialing with a new construct, followed by the final implant.This resulted in a 45 min delay.
Additional Manufacturer Narrative
Please note the following correction: the establishment fda registration number was corrected from 0001649390 to 3000931034.D3 (manufacturer entity) and g1 (manufacturing site).

• Brand Name: ASCEND FLEX RETROVERSION ROD
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15362519
• Report Number: 0001649390-2022-00057
• Device Sequence Number: 5227531
• Product Code: LXH
• UDI-Device Identifier: 03700386975011
• UDI-Public: 03700386975011
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/14/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MWF113
• Device Catalogue Number: MWF113
• Device Lot Number: CV0119045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 10/18/2022; 03/15/2023; 09/07/2023
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 11/14/2022; 03/16/2023; 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2019
• 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: Required Intervention
• Patient Sex: Unknown