MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS PERFORM REVERSED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number MWJ130

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the surgeon was attempting to take the size 36 glenosphere off and upsize due to stability issues the patient was having.After backing the set screw out as far as possible the screw came to a positive stop and would no longer spin.The surgeon used both the reverse ii and perform reverse extractors to attempt to remove the sphere but he ended up breaking the feet of the perform reverse extractor and bending the reverse ii extractor attempting to remove the sphere.The surgeon tried to re-advance the screw down just to reset everything but was unable to do so as the sphere screw was stuck and would not advance clockwise nor counterclockwise.We needed to go to a 42 sphere to lateralize the patient for stability but we were unable to do so.The 36 sphere is still in the patient.

• Brand Name: AEQUALIS PERFORM REVERSED
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12342985
• MDR Text Key: 267297854
• Report Number: 3000931034-2021-00312
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 00846832062522
• UDI-Public: 00846832062522
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: MWJ130
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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