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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC SALVATION 2 MIDFOOT NAIL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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WRIGHT MEDICAL TECHNOLOGY, INC SALVATION 2 MIDFOOT NAIL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number SMN10008
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/19/2022
Event Type  malfunction  
Event Description
Surgeon used device to place an 80mm nail into patient's left calcaneus.Adapter broke off into two pieces into patient wound.Surgeon used a second device of same kind, it also broke into 1 piece.Attempts to remove 3 broken pieces, only able to removed 1 of 3 pieces.Broken pieces left in the patient.Risk outweighed the benefits of removal.Patient was made aware of the event.
 
Event Description
Surgeon used device to place an 80mm nail into patient's left calcaneus.Adapter broke off into two pieces into patient wound.Surgeon used a second device of same kind, it also broke into 1 piece.Attempts to remove 3 broken pieces, only able to removed 1 of 3 pieces.Broken pieces left in the patient.Risk outweighed the benefits of removal.Patient was made aware of the event.
 
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Brand Name
SALVATION 2 MIDFOOT NAIL
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC
1023 cherry road
memphis TN 38117
MDR Report Key13598638
MDR Text Key286119340
Report Number13598638
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/18/2022
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 Model NumberSMN10008
Device Catalogue NumberN/A
Device Lot Number2379214
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/18/2022
Date Report to Manufacturer02/25/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/25/2022
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age14007 DA
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