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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER, INC. AEQUALIS HUMERAL NAIL SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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TORNIER, INC. AEQUALIS HUMERAL NAIL SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number AHN0337
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/31/2020
Event Type  malfunction  
Event Description
Doctor attempted to compress the fractures with the backslap apparatus but was unsuccessful; the backslap apparatus was removed and the 2 distal locking screws were placed and when the resident reattached the nail targeting jig (ref# ahn0337), it was unknowingly cross threaded. It is very difficult to reattach and align threads between the jig and the nail. The backslap apparatus was attached to jig and backslapped to compress fracture. When the resident removed the jig, they noticed the anterior tab on the jig had broken off and was embedded in the patient's bone (tabs help with alignment when reattaching the jig to the nail). Doctor attempted to remove the embedded tab from the bone with a tonsil clamp but was unsuccessful; he documented the tab was stable in the bone. The broken jig was not saved for or quality. Tornier sales rep present for procedure retained the jig and after terminally cleaning it, he returned it to tornier on for analysis - initial analysis shows the tab broke off from the inside out and it was highly likely that cross threading during reattachment was the cause. I have requested a report from the sales rep when the analysis from tornier is complete.
 
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Brand NameAEQUALIS HUMERAL NAIL SYSTEM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
TORNIER, INC.
10801 nesbitt avenue south
bloomington MN 55437
MDR Report Key10288679
MDR Text Key199253073
Report Number10288679
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAHN0337
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/25/2020
Event Location Hospital
Date Report to Manufacturer07/17/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/17/2020 Patient Sequence Number: 1
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