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

Model Number MWF113

Device Problems Break (1069); Fracture (1260)

Patient Problem Limb Fracture (4518)

Event Date 08/10/2022

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition.

Event 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 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.

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.

Manufacturer Narrative

Please note correction to b1, d9/h3.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 299459310
• Report Number: 0001649390-2022-00057
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03700386975011
• UDI-Public: 03700386975011
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention