MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE DISTAL STEM TRIAL 9DIA; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number ARS742301

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Limb Fracture (4518)

Event Date 08/10/2022

Event Type  malfunction  

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

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

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

The reported event could be confirmed, since aequalis flex revive distal stem trial 9dia was returned and found to be unusable due to the sheared off fragment being retained.The device inspection revealed the following: visual inspection: a visual inspection of the stem trial shows scratches, nicks and gouges indicating extensive usage.The proximal body connecting screw has sheared off inside of stem hindering removal.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 investigation, the root cause was attributed to a user related issue.The failure was caused by user error.Instruments must be inspected for wear/deformation prior to use in order to avoid fracture and separation of construct.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.

• Brand Name: AEQUALIS FLEX REVIVE DISTAL STEM TRIAL 9DIA
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15362492
• MDR Text Key: 299459280
• Report Number: 0001649390-2022-00056
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00846832068678
• UDI-Public: 00846832068678
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181420
• 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
• Report Date: 11/14/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: ARS742301
• Device Catalogue Number: ARS742301
• Device Lot Number: CR0118319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2019
• 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