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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 03/05/2021
Event Type  malfunction  
Event Description
It was reported that during an inspection in the warehouse it was noticed the failure of defective devices. It was noticed that the nail prox drop (b)(4) has a defective attachment. Three genesis ii tibial alignment spiked fixation rod (b)(4), the screwdriver release handle (b)(4), the journey ii bcs articular insert trial size 5-6 9mm right (b)(4), the journey ii bcs articular insert trial size 5-6 9mm left (b)(4), 0 deg 32 mm trial 48 mm (b)(4), the honeycomb (b)(4), the box chisel (b)(4), journey ii bcs articular insert trial size 1-2 11 mm right (b)(4) were noticed cracked. No case involved.
 
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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
UK 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 Key11593353
MDR Text Key243519197
Report Number1020279-2021-02488
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71751131
Device Catalogue Number71751131
Device Lot Number17CCL0002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/30/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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