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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PEGA MEDICAL, INC. FASSIER-DUVAL INTERMEDULLARY SYSTEM INTRAMEDULLARY NAIL

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PEGA MEDICAL, INC. FASSIER-DUVAL INTERMEDULLARY SYSTEM INTRAMEDULLARY NAIL Back to Search Results
Catalog Number MR232-S
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/11/2017
Event Type  Injury  
Manufacturer Narrative
This was a case of a (b)(6) patient with congenital pseudarthrosis of the tibia that had been treated using ø3. 2 mm fd implant. While using the male retriever instrument to retrieve the male implant, the coil portion of the coil puller shaft broke due to impaction. At the time of the removal, significant growth had occurred and the female and male components of the fd system were fully separated. Normally, the male remains inside the female which shields the end of the male component thus allowing secure engagement of the male retriever during the retrieval process. Due to the separation of the male and female, there was bone growth around the implant making it difficult for the male retriever to engage the male component. According to information provided by the company representative present at the surgery and the surgeon, impaction was used to attempt engagement. The surgeon managed to engage partially the coil puller. They decided to remove the removal tool with plans to drill further over the male component. When do so, the removal tool had actually engaged strongly with the male rod. However, the coil puller shaft broke proximal to the interface and left a portion of the removal tool in the tibia, still attached to the male portion of the rod. The impaction and the pulling force with the instrument partially engaged caused the coil portion of the coil puller shaft to break in the process. The broken coil portion and the fd male implant were left in the patient. This instrument is not designed to be impacted. This incident appears as an isolated case due to specific circumstances of bone growth around the male component and undue impaction of the instrument.
 
Event Description
The event occurred during a surgery for removal of a 3. 2 mm male component of the fassier-duval intermedullary system that was inserted inside the medullary canal of the tibia. While attempting to engage the male retriever instrument to retrieve the implant, the coil portion of the coil puller shaft of the male retriever instrument broke. The broken coil portion and the male implant were left in the patient.
 
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Brand NameFASSIER-DUVAL INTERMEDULLARY SYSTEM
Type of DeviceINTRAMEDULLARY NAIL
Manufacturer (Section D)
PEGA MEDICAL, INC.
1111 autoroute chomedey
laval, quebec H7W 5 J8
CA H7W 5J8
Manufacturer (Section G)
PEGA MEDICAL, INC.
1111 autoroute chomedey
laval, quebec H7W 5 J8
CA H7W 5J8
Manufacturer Contact
enrique garcia
1111 autoroute chomedey
laval, quebec H7W 5-J8
CA   H7W 5J8
MDR Report Key6771648
MDR Text Key81961778
Report Number3000327445-2017-00004
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 07/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberMR232-S
Device Lot Number160308-11
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/12/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/23/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/07/2017 Patient Sequence Number: 1
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