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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC AEQUALIS PERFORM REVERSE SHOULDER SYSTEM; SHOULDER PROSTHESIS FULL WEDGE BASEPLATE, 25MM
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TORNIER INC AEQUALIS PERFORM REVERSE SHOULDER SYSTEM; SHOULDER PROSTHESIS FULL WEDGE BASEPLATE, 25MM Back to Search Results
Catalog Number DWJ505
Device Problems Difficult to Advance (2920); Mechanical Jam (2983)
Patient Problem No Code Available (3191)
Event Date 06/14/2019
Event Type  malfunction  
Event Description
It was reported that during surgery the central screw would not engage with the screw driver through the baseplate holder.The screw was properly reverse threaded into the baseplate but after many attempt were unable to get the screw rotating.The issue resulted in a delay of 30 minutes which required additional anesthesia for the patient.
 
Event Description
It was reported that during surgery the central screw would not engage with the screw driver through the baseplate holder.The screw was properly reverse threaded into the baseplate but after many attempt were unable to get the screw rotating.The issue resulted in a delay of 30 minutes which required additional anesthesia for the patient.
 
Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunctioned or is related to a death or injury.- attachment: [complaint #(b)(4), (b)(6) 2019 perform reversed baseplate.Pdf].
 
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Brand Name
AEQUALIS PERFORM REVERSE SHOULDER SYSTEM
Type of Device
SHOULDER PROSTHESIS FULL WEDGE BASEPLATE, 25MM
Manufacturer (Section D)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
MDR Report Key8734512
MDR Text Key149194151
Report Number3004983210-2019-00034
Device Sequence Number1
Product Code PHX
Combination Product (y/n)N
PMA/PMN Number
K161742
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/20/2019
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 Expiration Date04/24/2024
Device Catalogue NumberDWJ505
Device Lot Number7311AU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2019
Initial Date Manufacturer Received 06/14/2019
Initial Date FDA Received06/26/2019
Supplement Dates Manufacturer Received06/14/2019
Supplement Dates FDA Received12/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age87 YR
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