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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NAIL PROX DROP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. NAIL PROX DROP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71751131
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2021
Event Type  Injury  
Event Description
It was reported that during surgery a ho loan kit was used and several inconvenient were noticed. The sureshot humeral drill guide probe failed. The proximal jig was faulty causing all of the proximal screws to miss the nail. All screws ended up being done by hand making perfect circles with both distal screws and proximal screws. It was reported a significant the case ended up delayed for over 2 hours. The procedure was completed with the same device and no injuries were reported.
 
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Brand NameNAIL PROX DROP
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
1450 brooks road
memphis, TN 38116
5123913905
MDR Report Key11616782
MDR Text Key243890847
Report Number1020279-2021-02694
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71751131
Device Catalogue Number71751131
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/05/2021 Patient Sequence Number: 1
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