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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVENTUS FLOWER ORTHOPEDICS INSERTER DRAW ROD, FLEX-THREAD INSERTER ROD

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CONVENTUS FLOWER ORTHOPEDICS INSERTER DRAW ROD, FLEX-THREAD INSERTER ROD Back to Search Results
Model Number 8439-1
Device Problems Entrapment of Device (1212); Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/03/2021
Event Type  malfunction  
Manufacturer Narrative
The draw rod had been inserted into the nail and was tightened appropriately by the surgeon during the case. According to the surgeon's narrative, he grabbed a t8 screwdriver to actuate the reduction device, but instead inadvertently continued actuating the draw rod.
 
Event Description
The event included the fracture of the tip of a draw rod. The fracture tip was left inside the driving feature of the nail, which was implanted in the patient.
 
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Brand NameINSERTER DRAW ROD, FLEX-THREAD
Type of DeviceINSERTER ROD
Manufacturer (Section D)
CONVENTUS FLOWER ORTHOPEDICS
100 witmer rd.
ste 280
horsham PA 19044
Manufacturer (Section G)
B&G MANUFACTURING (CONTRACT MANUFACTURER)
3067 unionville pike
#1822
hatfield PA 19440
Manufacturer Contact
amanda pentecost
100 witmer rd.
ste 280
horsham, PA 19044
2153234029
MDR Report Key12339194
MDR Text Key267248839
Report Number3009996260-2021-00012
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K202858
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8439-1
Device Catalogue Number8439-1
Device Lot Number0000011091
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 Received08/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/18/2021 Patient Sequence Number: 1
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