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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PEGA MEDICAL, INC. GAP ENDO-EXO MEDULLARY SYSTEM INTRAMEDULLARY NAIL,

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PEGA MEDICAL, INC. GAP ENDO-EXO MEDULLARY SYSTEM INTRAMEDULLARY NAIL, Back to Search Results
Catalog Number GAP-NDR100
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/11/2017
Event Type  malfunction  
Manufacturer Narrative
This was the first time this surgeon uses the gap system. The representative present at the surgery indicated that the canal was prepared for a ø4. 8 mm nail, but a ø5. 6 mm nail was finally implanted. Consequently, significant downwards pressure had to be applied to thread the nail in place, however, no impaction was necessary. The representative mentioned that the surgeon used both hands on the instrument to insert the nail. It is possible that the surgeon inadvertently unscrewed or over-tightened the barrel inducing undue efforts into the threaded shaft. The representative also indicated that it was hard to unscrew the nail driver from the nail. The barrel was rotated for a long time but the driver was not unthreading. The nail driver was eventually removed by pulling it out without impaction; however the tip of the driver was broken. The surgery was successfully completed but the broken piece remained in the patient.
 
Event Description
The threaded tip of the gap nail driver instrument broke. The failure was detected during the removal of the instrument at the end of the surgery. The gap nail driver is an instrument used for the insertion of the implantable gap endo-exo medullary system in the bone.
 
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Brand NameGAP ENDO-EXO MEDULLARY SYSTEM
Type of DeviceINTRAMEDULLARY NAIL,
Manufacturer (Section D)
PEGA MEDICAL, INC.
1111 autoroute chomede
laval, quebec H7W 5 J8
CA H7W 5J8
Manufacturer (Section G)
PEGA MEDICAL, INC.
1111 autoroute chomedey laval
laval, quebec H7W 5 J8
CA H7W 5J8
Manufacturer Contact
enrique garcia
1111 autoroute chomedey
laval, quebec H7W 5-J8
CM   H7W 5J8
MDR Report Key6771486
MDR Text Key82655775
Report Number3000327445-2017-00003
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160545
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 NumberGAP-NDR100
Device Lot Number110922-052
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2012
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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