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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC SALVATION¿ MIDFOOT NAIL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT,
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WRIGHT MEDICAL TECHNOLOGY INC SALVATION¿ MIDFOOT NAIL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT, Back to Search Results
Catalog Number SMN10008
Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/27/2021
Event Type  malfunction  
Event Description
The midfoot nail was successfully attached to the connector and implanted.The surgeon felt the handle "snap" on his final turn.It was then realized the connector nipples/wings broke off and the connector was removed from the nail.The surgeon could not retrieve the small metal fragments.The surgeon successfully compressed the nail and closed without issues.
 
Manufacturer Narrative
Device return is expected.Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
 
Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination shows that the tab for orientation is broken off and were not returned.Furthermore, the fracture surface finds evidence of a ductile overload fracture resulting from excessive force.Moreover the returned devices finds normal wear and tear consistent with reusable devices.The current instrument instructions for use state: "surgical instruments and instrument cases are susceptible to damage from prolonged use, and through misuse or rough handling", "inspect devices prior to use for damage during shipment or storage or any out-of-box defects that might increase the likelihood of fragmentation during a procedure", and "the useful life of these devices depends on many factors, including the method and duration of each use and the handling between uses".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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by ductile overload fracture resulting from excessive force.If any additional information is provided, the investigation will be reassessed.
 
Event Description
The midfoot nail was successfully attached to the connector and implanted.The surgeon felt the handle "snap" on his final turn.It was then realized the connector nipples/wings broke off and the connector was removed from the nail.The surgeon could not retrieve the small metal fragments.The surgeon successfully compressed the nail and closed without issues.
 
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Brand Name
SALVATION¿ MIDFOOT NAIL
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT,
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY INC
1023 cherry rd
memphis TN 38117
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13338174
MDR Text Key290285947
Report Number3010667733-2022-00026
Device Sequence Number1
Product Code LXH
UDI-Device Identifier00840420194817
UDI-Public00840420194817
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/12/2022
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 NumberSMN10008
Device Lot Number2519306
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/27/2021
Initial Date FDA Received01/24/2022
Supplement Dates Manufacturer Received06/15/2022
Supplement Dates FDA Received07/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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