MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE TRIAL SPACER 9DIA 20MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	ARS742401
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "surgeon built a 150mm revive stem trial for the patient.As the surgeon was connecting the tray/poly trial onto the proximal body, the proximal body disengaged from the spacer trial and fell off.It was then noticed the locking tabs on the spacer broke apart, leaving the proximal body nothing to attach to.Because the proximal body was no longer secured to the stem trial construct, there was no way to retrieve the rest of the stem trial that was in the canal.No pliers or graspers were strong enough to retrieve the stem.The surgeon eventually preformed a bone osteotomy to extract the remaining stem trial.Case was delayed 45 minutes.All reported debris was extracted from patient.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "surgeon built a 150mm revive stem trial for the patient.As the surgeon was connecting the tray/poly trial onto the proximal body, the proximal body disengaged from the spacer trial and fell off.It was then noticed the locking tabs on the spacer broke apart, leaving the proximal body nothing to attach to.Because the proximal body was no longer secured to the stem trial construct, there was no way to retrieve the rest of the stem trial that was in the canal.No pliers or graspers were strong enough to retrieve the stem.The surgeon eventually preformed a bone osteotomy to extract the remaining stem trial.Case was delayed 45 minutes.All reported debris was extracted from patient.".
Additional Manufacturer Narrative
Please note the correction to d4 gtin.The reported event could be confirmed, since the device was returned and matches the alleged failure mode.The device inspection revealed the following: an inspection of the returned device shows a brittle fracture on both tabs at the bottom, which connect with the trial stem.Only one of these tabs was included in the return.Additionally, signs of wear are visible at the top of the trial, with deep circular striations appearing in the chamfer of the counter boar that interacts with the trial head.Due to the nature of the returned device, functional inspection and dimensional inspections were not considered necessary or possible due to visible damage rendering it non-functional with measurable features of the instrument missing.Based on investigation, the root cause was attributed to a combination of wear & user related issue.The failure was caused by an improper handling, extensive usage & application of excessive mechanical force.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 more information is provided, the case will be reassessed.

• Brand Name: AEQUALIS FLEX REVIVE TRIAL SPACER 9DIA 20MM
• Common Device Name: 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: 20987166
• Report Number: 0001649390-2024-00722
• Device Sequence Number: 8580876
• Product Code: HSD
• UDI-Device Identifier: 00846832068739
• UDI-Public: (01)00846832068739(11)190220(10)CR0718319
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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 Catalogue Number: ARS742401
• Device Lot Number: CR0718319
• 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: 11/27/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2019
• 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