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

Catalog Number GAP-N56-28

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017)

Patient Problem Non-union Bone Fracture (2369)

Event Date 10/14/2017

Event Type  Injury  

Manufacturer Narrative

This gap-n56-28 nail was inserted into a (b)(6) year-old overweight female patient with osteoporotic bone (weak bone).The femur presented with a narrow shaft and a valgus deformation.The failure occurred approximately three weeks post-surgery while the patient was sitting to put her shoe on.The weight of the patient (around 60 kg) was well above the weight limit of the nail, which is around 40 kg.Furthermore, the nail was inserted in retrograde instead of antegrade.Anterograde insertion is the preferred approach in patients with proximal fractures such as this case since it maximizes the resistance proximally where it is most needed.Retrograde insertion places the weakest section of the nail (the tip of the nail) proximally where the highest loads are experienced due to the proximity of the fracture or osteotomy and the lever arm of the hip.The surgeon had no choice but to insert the nail in retrograde due to specific patient conditions (distal osteotomy).The combination of high loads due to the patient being overweight and the retrograde insertion, caused the nail to fail proximally at the distal locking screw hole.The broken nail has been successfully retrieved and replaced for another nail with a larger diameter.

Event Description

A gap-n56-28 nail was used in a (b)(6) year-old overweight patient to correct a valgus deformity.The nail was inserted in retrograde following osteotomy and correction of the right femur.Three weeks post-surgery the nail failed proximally, specifically at the distal screw hole.

• Brand Name: GAP ENDO-EXO MEDULLARY SYSTEM
• Type of Device: INTRAMEDULLARY 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 Key: 7024387
• MDR Text Key: 91808596
• Report Number: 3000327445-2017-00005
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K160545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: GAP-N56-28
• Device Lot Number: 121218-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2017
• Initial Date FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 60