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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS, INC. ARCUS STAPLE SYSTEM
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NEXTREMITY SOLUTIONS, INC. ARCUS STAPLE SYSTEM Back to Search Results
Catalog Number ARC-1008K
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2021
Event Type  malfunction  
Manufacturer Narrative
If additional information is provided that changes the outcome of the investigation a follow-up report will be filed.
 
Event Description
Drill fractured during surgery.Surgery completed successfully with different product from another set.No information about patient/surgeon provided due to data privacy, product supposed to be returned.
 
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Brand Name
ARCUS STAPLE SYSTEM
Type of Device
STAPLE
Manufacturer (Section D)
NEXTREMITY SOLUTIONS, INC.
1195 polk drive
warsaw IN 46580
Manufacturer (Section G)
NEXTREMITY SOLUTIONS, INC.
1195 polk drive
warsaw IN 46580
Manufacturer Contact
travis christman
1195 polk drive
warsaw, IN 46582
MDR Report Key12040029
MDR Text Key265152706
Report Number3009540749-2021-00028
Device Sequence Number1
Product Code JDR
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K151160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue NumberARC-1008K
Device Lot Number168525718A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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